fda
103 records
FDA Recall: Elekta, Inc. — Class II
20260218
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan referen | Product: Brand Name: Leksell GammaPlan Product...
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FDA Recall: Elekta, Inc. — Class II
20260121
Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,Wi | Product: MOSAIQ Oncology Information System wit...
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FDA Device Recall: Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfe
2026-03-25
Class II — Due to adapter not being properly aligned or locked in place.
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FDA Device Recall: Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning
2026-02-18
Class II — Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment pla...
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FDA Device Recall: MOSAIQ Oncology Information System with Particle Therapy License (License Kit 4
2026-01-21
Class II — Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field...
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FDA Device Recall: MOSAIQ Oncology Information System
2025-02-19
Class II — Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
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FDA Recall: Elekta, Inc. — Class II
20231213
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewG | Product: ELEKTA LIMITED Elekta Infinity, REF XR...
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FDA Recall: Elekta, Inc. — Class II
20231213
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewG | Product: ELEKTA LIMITED Elekta Synergy Platform...
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FDA Recall: Elekta, Inc. — Class II
20231213
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewG | Product: ELEKTA LIMITED Versa HD, REF XRT 2121,...
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FDA Device Recall: ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medi
2023-12-13
Class II — Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detect...
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FDA Device Recall: ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-
2023-12-13
Class II — Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detect...
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FDA Device Recall: ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation
2023-12-13
Class II — Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detect...
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FDA Device Recall: ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Ther
2023-12-13
Class II — Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detect...
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FDA Device Recall: ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle
2023-12-13
Class II — Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detect...
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FDA Device Recall: ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Char
2023-12-13
Class II — Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detect...
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FDA Device Recall: Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a.
2023-06-07
Class II — A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601
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FDA Device Recall: Monaco RTP System. Used to make treatment plans for patients with prescript
2023-03-15
Class II — Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.
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FDA Device Recall: Oncentra Brachy users using version 4.0 and above with Applicator Modeling licen
2021-11-03
Class II — Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
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FDA Device Recall: Elekta Medical Linear Accelerator (EMLA), configured as follows: a. Elekta Pr
2021-10-20
Class II — There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the...
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FDA Device Recall: MOSAIQ Oncology Information System
2021-10-06
Class II — A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.
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FDA Device Recall: Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.8
2021-06-09
Class II — Malware attack
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FDA Recall: Elekta, Inc. — Class II
20200617
potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray. | Product: Elekta Unity, UDI 05060191071321, Image-guided radiati...
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FDA Device Recall: Elekta Unity, Image-Guided Radiation Therapy System
2020-07-08
Class II — There have been reports of excessive heating in the MRL Gradient Connection Module.
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FDA Device Recall: Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Produc
2020-06-17
Class II — potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray.
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FDA Device Recall: Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage
2020-05-06
Class II — A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a Leksell Vantage Stereotactic A...
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FDA Device Recall: Elekta MONACO RTP Sytem, radiation treatment planning software system - Product
2020-05-06
Class II — The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose.
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FDA Device Recall: Monaco Radiation Treatment Planning System (RTP) System
2019-12-18
Class II — Monaco is using the incorrect energy when optimizing and calculating dose.
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FDA Device Recall: Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usa
2019-10-02
Class II — It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
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FDA Device Recall: Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Us
2019-10-02
Class II — It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
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FDA Device Recall: Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnet
2019-07-24
Class II — The QA software solution to perform the MR to MV alignment check, does not display the stored MR to MV offset values. The user is unable to independently inspect the values during their QA.
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FDA Device Recall: Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Un
2019-04-17
Class II — Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of the anatomy ...
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FDA Device Recall: Monaco Radiation Treatment Planning (RTP) System
2019-03-06
Class II — If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco¿ will automatically use this optimization model again when proceeding with the online p...
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FDA Device Recall: MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology infor
2019-02-20
Class II — There is a potential that Wedge IDs were not included in the DICOM RT PLAN sent from the TPS, which will cause the field in MOSAIQ to be created with no wedge. Treatment of a field without...
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FDA Device Recall: MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology info
2019-01-02
Class II — If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the copied field will have the same isocenter as the parent and that isocenter ma...
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FDA Device Recall: ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Syne
2018-08-29
Class II — There is a potential for an uncontrolled extension of iViewGT / XVI detector arms.
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FDA Device Recall: MOSAIQ Oncology Information System
2018-08-29
Class II — Order Status Remains Approved When Should Indicate Complete.
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FDA Device Recall: Integrity R1.2
2018-03-07
Class II — Potential for positional errors following automatic table movement (ATM).
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FDA Device Recall: Agility with Integrity R3.2
2018-03-07
Class II — Potential for positional errors following automatic table movement (ATM).
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FDA Recall: Elekta, Inc. — Class II
20170719
If the gantry module is replaced after original installation the configuration settings may be missing. The identified risk for this issue is electric | Product: Leksell Gamma Knife Icon is a telether...
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FDA Device Recall: Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irrad
2017-07-19
Class II — If the gantry module is replaced after original installation the configuration settings may be missing. The identified risk for this issue is electrical safety for technicians doing mainten...
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FDA Device Recall: Monaco RTP System Product Usage: Used to make treatment plans for patients w
2017-01-18
Class II — Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.
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FDA Device Recall: Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation
2017-01-18
Class II — Cross profile for Varian 60 degree wedge shows "horns."
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FDA Recall: Elekta, Inc. — Class II
20161221
Edits to Particle field definition parameters may not be saved when the field definition window is saved. | Product: MOSAIQ Oncology Information System The product is used to manage workflows for ...
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FDA Recall: Elekta, Inc. — Class II
20160914
There have been instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue fai | Product: Medical Linear Accelerator
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FDA Recall: Elekta, Inc. — Class II
20160601
If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibili | Product: iGUIDE System, for patient positioning...
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FDA Recall: Elekta, Inc. — Class II
20160106
Incorrect drug dosage due to "Age Limit" and patient weight data item issue. | Product: MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workfl
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FDA Device Recall: MOSAIQ Oncology Information System The product is used to manage workflows f
2016-12-21
Class II — Edits to Particle field definition parameters may not be saved when the field definition window is saved.
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FDA Device Recall: Monaco TRP System The Monaco system is used to make treatment plans for patient
2016-12-07
Class II — Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm.
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FDA Device Recall: Monaco RTP System; Used to make treatment plans for patients with prescriptions
2016-12-07
Class II — Incorrect Dose when using the reset function.
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FDA Device Recall: Monaco RTP System The Monaco system is used to make treatment plans for patient
2016-10-19
Class II — When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU ...
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FDA Device Recall: Medical Linear Accelerator
2016-09-14
Class II — There have been instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.
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FDA Device Recall: HexaPOD evo RT System Product Usage: The intended use of the device is the c
2016-09-07
Class II — Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position.
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FDA Device Recall: Monaco RTP System Used to make treatment plans for patients with prescription
2016-09-07
Class II — In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved in the same session, it is possible that the delete...
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FDA Device Recall: MOSAIQ Oncology Information System
2016-08-03
Class II — It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order.
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FDA Device Recall: MOSAIQ Oncology Information System
2016-07-06
Class II — It is possible that that the selected Plan-of-the Day could be accidently changed by scrolling the mouse wheel up and down and inadvertently selecting another plan.
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FDA Device Recall: iGUIDE System, for patient positioning, with assistance of a 30 Tracking System
2016-06-01
Class II — If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up w...
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FDA Device Recall: Radionuclide Radiation Therapy System Product The product is a teletherapy de
2016-05-04
Class II — The latches of the frame adapter can be locked even if the locating pins of the frame adapter is not inserted into the corresponding holes in the coordinate frame.
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FDA Device Recall: MOSAIQ Oncology Information System MOSAIQ is an oncology information system u
2016-01-06
Class II — Incorrect drug dosage due to "Age Limit" and patient weight data item issue.
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FDA Recall: Elekta, Inc. — Class II
20150218
Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail. | Product: Precise Digital Accelerator Intended to be used for radiation therapy treatments ...
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FDA Device Recall: MOSAIQ Oncology Information System. Used to manage workflows for treatment pl
2015-12-23
Class II — First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies drugs in their database to reflect market and formulary changes. In FDB Framework v2.0, those ...
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FDA Device Recall: Monaco - Radiation Treatment Planning used to make treatment plans for patients
2015-11-04
Class II — Unintended update of Dose and MU and Incorrect Assignment of Bolus.
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FDA Device Recall: XiO Radiation Treatment Planning System. Used to create treatment plans for any
2015-10-28
Class II — Incorrect Treatment Delivery Using Third Party Fixed Wedges.
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FDA Device Recall: MOSAIQ Oncology Information System MOSAIQ is an oncology information system use
2015-07-22
Class II — A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones.
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FDA Device Recall: Elekta Precise Treatment Table
2015-03-25
Class II — It is possible to position the Treatment Table with errors greater than 5mm and no inhibits are displayed, if the positional sensors are not correctly installed during corrective maintenanc...
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FDA Device Recall: Precise Digital Accelerator Intended to be used for radiation therapy treatme
2015-02-18
Class II — Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.
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FDA Recall: Elekta, Inc. — Class II
20141126
A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose rounding error on printed reports. | Product: MOSAIQ Product Usage: MOSAIQ is an oncology information...
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FDA Recall: Elekta, Inc. — Class II
20140312
During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. | Product: Agility. Version 3.0 of the Integrity interface and co...
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FDA Recall: Elekta, Inc. — Class II
20140312
During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. | Product: Desktop Pro TM linear accelerator control software inte...
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FDA Recall: Elekta, Inc. — Class II
20140129
When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it | Product: XiO RTP System The XiO RTP System i...
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FDA Device Recall: MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manag
2014-11-26
Class II — A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose rounding error on printed reports.
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FDA Device Recall: Laksell Gamma Knife Perfexion
2014-11-05
Class II — Elekta has become aware that the latches may be locked before they have been fully turned resulting in a poorly locked frame.
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FDA Device Recall: FOCAL Sim Workstation, Radiation Treatment Planning System. Used for patien
2014-09-10
Class II — When DICOM is exporting an arc plan (VMAT, Dynamic Conformal of 3D Static Arcs) and using the Composite Field Sequencing (CFS) feature, the DICOM exported plan will not match the approved t...
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FDA Device Recall: MOSAIQ, an oncology information system used to manage workflows for treatment pl
2014-06-25
Class II — When using CMA, if the user hovers the mouse pointer exactly above the direction dropdowns and then uses the mouse thumbwheel or touchpad scroll bar, the direction selection might change wh...
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FDA Device Recall: Synergy XVI Intended for radiation therapy treatment.
2014-06-25
Class II — XVI can incorrectly calculate the target position of the treatment table.
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FDA Device Recall: iGUIDE System Product Usage: The intended use of the device is the control o
2014-06-25
Class II — A bug in the software prevents the iGUIDE software from logging off.
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FDA Device Recall: HexaPOD evo RT Couchtop. To support and aid in positioning a patient during r
2014-05-07
Class II — If screws are not properly tightened with a torque wrench they may become loose over time.
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FDA Device Recall: Agility. Version 3.0 of the Integrity interface and control software for the El
2014-03-12
Class II — During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
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FDA Device Recall: Desktop Pro TM linear accelerator control software intended to assist a licensed
2014-03-12
Class II — During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
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FDA Device Recall: Integrity. Version 1.1 of the Integrity interface and control software for the
2014-03-12
Class II — During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
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FDA Device Recall: RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user inter
2014-03-12
Class II — During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
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FDA Device Recall: Agility. Version 3.1 of the Integrity interface and control software for the El
2014-03-12
Class II — During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
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FDA Device Recall: All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, A
2014-03-12
Class II — Customers are resetting the default values outside recommended factory settings.
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FDA Device Recall: DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear acc
2014-03-05
Class II — It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems
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FDA Device Recall: Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy
2014-02-26
Class II — Potential collision risk when using XVI and external beam shaping devices.
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FDA Device Recall: Synergy XVI XVI can incorrectly calculate the target position of the treatmen
2014-02-26
Class II — XVI can incorrectly calculate the target position of the treatment table.
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FDA Device Recall: XiO RTP System. Used to create treatment plans for any cancer patient for who
2014-02-12
Class II — When bolus is present, the Effective Depth (with bolus) to the weight point returned on the Source Data Report is incorrect.
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FDA Device Recall: XiO RTP System The XiO RTP System is used to create treatment plans for any c
2014-01-29
Class II — When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it should be even after saving and re-ope...
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FDA Recall: Elekta, Inc. — Class II
20131113
Potential for clinical errors. | Product: Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of
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FDA Device Recall: Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories T
2013-11-13
Class II — Potential for clinical errors.
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FDA Device Recall: Monaco RTP System Radiation treatment planning
2013-10-02
Class II — Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values.
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FDA Device Recall: Monaco RTP System Radiation Therapy Treatment Planning System. Radiation tre
2013-10-02
Class II — Patient needs to be positioned as indicated by the treatment plan.
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FDA Device Recall: Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated f
2013-06-05
Class II — Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0.
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FDA Device Recall: Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.
2013-03-20
Class II — The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name.
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FDA Device Recall: Elekta, Apex add-on Micro MLC, collimator for radiation therapy.
2013-03-06
Class II — If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions.
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FDA Device Recall: Monaco RTP System. Radiation treatment planning.
2013-02-27
Class II — The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.
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FDA Recall: Elekta, Inc. — Class II
20121107
A patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a treatment filed in MOSAIQ. | Product: MOSAIQ MOSAIQ is an image-enabled electronic medica...
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FDA Recall: Elekta, Inc. — Class II
20120919
Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Ape | Product: Multileaf Collimator To be used for...
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FDA Recall: Elekta, Inc. — Class II
20120718
Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports. | Product: Focal SIM Planning of radiation therapy
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FDA Device Recall: MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used
2012-11-07
Class II — A patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a treatment filed in MOSAIQ.
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FDA Device Recall: Oncentra External Beam 4.1. Radiation treatment planning software designed to
2012-10-31
Class II — During the planning process the beam weights can be changed by the customers. When the beam weights are changed and renumbered and this happens during the dose calculation it is possible to...
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FDA Device Recall: Multileaf Collimator To be used for single or multiple fractions, delivered a
2012-09-19
Class II — Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.
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FDA Device Recall: Focal SIM Planning of radiation therapy
2012-07-18
Class II — Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
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FDA Device Recall: Monaco Product Usage: Planning of radiation therapy
2012-07-18
Class II — Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
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lobbying
2 records
Lobbying Firm: ELEKTA, INC.
Registered lobbying firm — Washington, DC — Manufacturer of cancer care medical devices, software, and therapy planning products
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ny_corps
1 records
NY Corp: ELEKTA, INC.
2003-08-26
FOREIGN BUSINESS CORPORATION | County: Albany | Jurisdiction: Georgia
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USASpending
1 records
Federal Award: ELEKTA INC — $3,472,862
2026-05-29
MODALITY: RT LINAC/CT PURCHASE ORDER: 596B50096 STATION: VAMC LEXINGTON VA HEALTH CARE SYSTEM REQUIREMENT: SEP FY25 EQ
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