INVACARE CORP — Federal Records

FDA Device Recall: Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Mo 2024-03-13

Class II — Invacare Homecare & G-Series Bed Components identified with a potential weld defect leads to premature weld failures to occur on these components

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FDA Device Recall: Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canad 2022-07-20

Class III — Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.

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FDA Device Recall: Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V 2022-06-01

Class II — The battery wiring harness on affected wheelchairs may become disconnected during shipment from the factory or during wheelchair use traversing large obstacles or after a jolt or impact to ...

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FDA Device Recall: Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model 2022-01-12

Class II — Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to the system following the incor...

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FDA Device Recall: Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory 2020-12-09

Class II — Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization (P.E.) valve assembly in the concentrator may lead to failure that can result in self-extin...

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FDA Device Recall: Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P Th 2018-12-12

Class II — Invacare has identified via customer complaints, the potential for the mounting bolt connecting the caster to the base frame of the patient lifts to become loose. Loose hardware can cause w...

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FDA Recall: Invacare Corporation — Class II 20170215

A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire. | Product: Bariatric Bed - BARPKG-IVC 1633

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FDA Recall: Invacare Corporation — Class II 20170215

A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire. | Product: Junction Box - 1104343 and 1193560

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FDA Device Recall: Assist Bed Rail - 6632 2017-06-07

Class II — A typographical error was noted within the user manual for the 6632 Assist Bed Rail which could result in the Assist Bed Rails being installed incorrectly.

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FDA Device Recall: Bariatric Bed - BARPKG-IVC 1633 2017-02-15

Class II — A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire.

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FDA Device Recall: Junction Box - 1104343 and 1193560 2017-02-15

Class II — A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire.

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FDA Device Recall: Bariatric Bed - BAR600IVC 2017-02-15

Class II — The junction box used in the bariatric bed may emit sparks and result in a fire.

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FDA Recall: Invacare Corporation — Class II 20160817

The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit | Product: Invacare¿ Foot Section for Semi & Full...

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FDA Recall: Invacare Corporation — Class II 20160817

The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit | Product: Invacare¿ Bariatric Bed with mattress ...

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FDA Recall: Invacare Corporation — Class II 20160817

The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit | Product: Invacare¿ Bariatric Bed w/o mattress &...

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FDA Device Recall: Invacare¿ Foot Section for Semi & Full Electric Beds, Junction Boxes, Produc 2016-08-17

Class II — The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in ...

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FDA Device Recall: Invacare¿ Bariatric Bed with mattress and rails , Junction Boxes, Product Us 2016-08-17

Class II — The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in ...

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FDA Device Recall: Invacare¿ Bariatric Bed w/o mattress & rails, Junction Boxes, Product Usage: 2016-08-17

Class II — The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in ...

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FDA Device Recall: Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per 2016-08-17

Class II — The rear gradation scale was screen printed upside down on the flowmeter gauge.

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FDA Device Recall: lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per ca 2016-08-17

Class II — The rear gradation scale was screen printed upside down on the flowmeter gauge.

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FDA Device Recall: Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corpora 2015-08-19

Class II — The batteries used in the Invacare¿ Pronto¿ Air Personal Transporter models power wheelchairs have the possibility to overheat during charging which could potentially result in leaking batt...

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FDA Device Recall: G- Series Beds; G29 full length bed rails assembly 2015-02-11

Class II — Invacare identified that the rail mounting bracket on the G29 full length bed rail was out of specification for entrapment safety.

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FDA Recall: Invacare Corporation — Class II 20140730

M41 Powered Wheelchairs received through Invacare Service Parts (ISP) have controllers that were programmed in a way this is not aligned to standard f | Product: MK5 NX Controller--Wheelchair controll...

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FDA Device Recall: MK5 NX Controller--Wheelchair controller 2014-07-30

Class II — M41 Powered Wheelchairs received through Invacare Service Parts (ISP) have controllers that were programmed in a way this is not aligned to standard factory settings. The controller during...

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FDA Device Recall: Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec 2014-07-16

Class II — The Aquatec¿ Fixed Backrest withstands a load of only 250 newtons at uneven load. This may result in the Fixed Backrest becoming detached from the frame.

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FDA Device Recall: Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. w 2014-01-15

Class II — The wheels on Tracer IV wheelchairs (Tracer IV 24" seat width, 450 lbs. weight capacity manual wheel chair) were warped and wobbled when rolled.

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FDA Recall: Invacare Corporation — Class II 20130828

There is a possibility of elevated temperatures in the seat pad. In addition, the hospital cord set does not agree with the labeling (information in m | Product: CHAMPION Medical Recliner, AC Powered ...

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FDA Device Recall: Invacare Power Wheelchair, one per box To provide mobility to a person restri 2013-10-02

Class II — Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type joysticks.

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FDA Device Recall: CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carto 2013-08-28

Class II — There is a possibility of elevated temperatures in the seat pad. In addition, the hospital cord set does not agree with the labeling (information in manual).

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FDA Device Recall: Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a 2013-02-13

Class II — The potential exists for the wheel to rotate freely despite engagement of hub brake.

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FDA Device Recall: Invacare Height Adjustable (walking) Canes, Model Numbers: 8916, 8917, and 409 2012-12-26

Class II — Following their receipt of several customer complaints, Invacare recalled their height adjustable walking canes. The device was recalled from distribution based on reports indicating that ...

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FDA Device Recall: TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model 2012-07-11

Class II — Invacare Corporation decided to recall the product because of a potential risk of fire and serious injury. The post fuse assemblies could potentially have a short between the positive ring...

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