| 2024-01-22 |
Class II
|
Ongoing |
Z-1251-2024 |
Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54… |
— |
Invacare Homecare & G-Series Bed Components identified with a potential weld defect leads to premature weld failures to occur on these components |
| 2023-06-15 |
Class II
|
Ongoing |
Z-2445-2023 |
DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1… |
— |
Premature failure of the seat during use, the plastic eyelets of the folding mechanism of the device's seat can break, and in a worst-case crossbar also breaks … |
| 2022-06-10 |
Class III
|
Ongoing |
Z-1369-2022 |
Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model) |
— |
Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required. |
| 2022-03-30 |
Class II
|
Ongoing |
Z-1130-2022 |
Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V |
— |
The battery wiring harness on affected wheelchairs may become disconnected during shipment from the factory or during wheelchair use traversing large obstacles … |
| 2021-11-12 |
Class II
|
Ongoing |
Z-0447-2022 |
Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101… |
— |
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 t… |
| 2021-11-12 |
Class II
|
Ongoing |
Z-0446-2022 |
Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) … |
— |
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 t… |
| 2021-11-12 |
Class II
|
Ongoing |
Z-0445-2022 |
Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Mo… |
— |
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 t… |
| 2020-10-30 |
Class II
|
Terminated |
Z-0514-2021 |
Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen… |
— |
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 … |