Recall Z-1251-2024 ยท LLI Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
Invacare Corporation
Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4) BAR5490IVC (5) BAR5000IVC (6) 5000IVC (7) 5490IVC (8) 5490LOW
| Date | Mar 4, 2024 (initiated Jan 22, 2024) |
| Status | Open, Classified |
| Reason | Invacare Homecare & G-Series Bed Components identified with a potential weld defect leads to premature weld failures to occur on these components |
| Root cause | Process design |
| Action | Invacare issued Urgent Medical Device Correction letter on 12/22/23. Letter states reason for recall, health risk and action to take: 1.Please locate your affected products Please review your records to locate the affected components. Above is a list of model numbers to assist you with this process. 2. Please contact your provider at the number listed below to have the bed component replaced. |
| Quantity | 8,117 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.