fda
19 records
FDA Device Recall: Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Ki
2025-10-01
Class II — Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.
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FDA Device Recall: Chromophare Surgical Light System , REF CH00000001
2024-04-17
Class II — Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.
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FDA Device Recall: S-Series Equipment Management System; Model Number(s):0682400550; UDI: 076133274
2021-03-31
Class II — The manufacturer has become aware that there is a likelihood that the S-Series Equipment Management System Capacitive Touch Controls on the MFRs rotational electrical magnetic brakes may di...
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FDA Recall: Stryker Communications — Class II
20190911
The mounts on the monitor may have an insufficient weld. | Product: Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromoph
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FDA Recall: Stryker Communications — Class II
20190529
There is a potential the joint in the suspension of the device is insufficiently assembled. | Product: EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System...
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FDA Device Recall: Berchtold Chromophare F628 Surgical Lights. Product Usage: The medical lig
2019-09-18
Class II — The back cover of the light head was insufficiently assembled and could potentially fall off the light.
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FDA Device Recall: Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical lig
2019-09-18
Class II — The back cover of the light head was insufficiently assembled and could potentially fall off the light.
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FDA Device Recall: Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component o
2019-09-11
Class II — The mounts on the monitor may have an insufficient weld.
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FDA Device Recall: EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgica
2019-05-29
Class II — There is a potential the joint in the suspension of the device is insufficiently assembled.
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FDA Device Recall: Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component o
2018-03-07
Class II — The mounts on the monitor may have an insufficient (missing or incomplete) weld.
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FDA Device Recall: Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medica
2017-06-14
Class II — The exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the snap ring to be seated correctly. If this is the case, there could be insufficien...
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FDA Device Recall: The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the op
2017-04-05
Class II — The potential hazard that can arise for the combination of the missing screws and the overloading by the end user is insufficient mount force that causes the equipment to fall.
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FDA Recall: Stryker Communications — Class II
20140723
During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present | Product: SHAPE ARM, SINGLE WITH GCX MOUNT, an a...
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FDA Device Recall: SHAPE ARM, SINGLE WITH GCX MOUNT, an articulating, arm bracket that is attached
2014-07-23
Class II — During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present.
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FDA Device Recall: SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the servic
2014-07-23
Class II — During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present.
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FDA Device Recall: BAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the ser
2014-07-23
Class II — During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present.
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FDA Device Recall: BAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the serv
2014-07-23
Class II — During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present.
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FDA Recall: Stryker Communications, Inc. — Class II
20130116
Stryker has become aware that there is a low likelihood of incomplete engagement of the Spring Arm Circlip during service or replacement of the Sprin | Product: (l) Visum Halogen Surgical Light, (2) ...
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FDA Device Recall: (l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker Flat
2013-01-16
Class II — Stryker has become aware that there is a low likelihood of incomplete engagement of the Spring Arm Circlip during service or replacement of the Spring Arm. If the Spring Arm Circlip is not...
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ny_corps
1 records
NY Corp: STRYKER COMMUNICATIONS LLC
2019-01-14
DOMESTIC LIMITED LIABILITY COMPANY | County: Albany | Jurisdiction: New York
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