CLASS II ONGOING Device recall · Reported 12 Jan 2022 · FDA Enforcement Report
Aviva FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module recalled
Invacare is recalling Aviva FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module, distributed nationwide in the US. The recall was initiated on 12 Nov 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0446-2022
- FDA event ID
- 89062
- Recalling firm
- Invacare, Elyria, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Nov 2021
- FDA classified
- 3 Jan 2022
- Reported
- 12 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Wheelchairs, Beds & Lifts
Timeline
| 12 Nov 2021 | Recall initiated by company | |
| 3 Jan 2022 | Classified by FDA | +52 days |
| 12 Jan 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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 incorrect deceleration profile, resulting in potential injury
Product as listed by the FDA
Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: IFX-20R, IFX-20SP, IFX-20MP, IFX-20C
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Australia, Thailand, New Zealand.
Questions about this recall
Why was it recalled?
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 incorrect deceleration profile, resulting in potential injury
Which lots are affected?
LiNX Gyro firmware version 6.1.2 UDI-DI Numbers: IFX-20C 00841447111627 IFX-20MP 00841447111658 IFX-20R 00841447111634 IFX-20SP 00841447111641 IFX20WIDE 00841447111658
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Australia, Thailand, New Zealand.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 89062| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module recalled | Invacare | Other | Nationwide | |
| CLASS II | Aviva Storm RX with LiNX Gyro Power Wheelchair recalled by Invacare | Invacare | Other | Nationwide |
More recalls from Invacare
All 35| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Dolomite Gloss Rollator - intended to support during recalled | Invacare | Foreign Material | Nationwide |
| Device | CLASS III | Platinum 5NXG Oxygen Concentrator recalled by Invacare | Invacare | Other | 18 states |
| Device | CLASS II | TDX SP2 recalled by Invacare | Invacare | Device Malfunction | Nationwide |
| Device | CLASS II | Aviva Storm RX with LiNX Gyro Power Wheelchair recalled by Invacare | Invacare | Other | Nationwide |
| Device | CLASS II | TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module recalled | Invacare | Other | Nationwide |
Other Wheelchairs, Beds & Lifts recalls
All 175| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Power F2 Powered Fastening System, Power F2 recalled by Ferno-Washington | Ferno-Washington | Potency & Assay | Nationwide |
| Device | CLASS II | Rollator, Bariatric, Basic Steel, Burgundy recalled | Medline Industries | Foreign Material | Nationwide |
| Device | CLASS II | Rollator, Bariatric, Basic Steel, Blue recalled by Medline Industries | Medline Industries | Foreign Material | Nationwide |
| Device | CLASS II | Quantum Rehab Quantum 4Front 2HD recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |
| Device | CLASS II | Quantum Rehab Q6 Edge 2.0 (ilevel) recalled by Pride Mobility Products | Pride Mobility Products | Device Malfunction | Nationwide |