Recall Z-1943-2020 ยท FSA Lift, Patient, Non-Ac-Powered
Handicare AB
EVA Floor Lifts, Model Numbers: 400, 450, 600
| Date | Jun 15, 2016 |
| Status | Open, Classified |
| Reason | After feedback from customers and internal suspicion, Handicare has become aware that abnormal use of Eva-lifts could lead to a deterioation in the joint of the liftarm. This could lead to injury if the joint breaks. All lifts must therefore be checked and reported back to the manuafacturer. |
| Root cause | Device Design |
| Action | The firm notified their consignees on 06/15/2016 by email. The notice explained the issue of wear in the joint of the lift arm due to abnormal use in heavy loads and/or many lifts. The consignee was directed to inspect the lifts in order to identify gaps and/or cracks and to report to the local Handicare sales representative and to Handicare. On April 4, 2019, the firm sent a reminder notice on 04/04/2019 |
| Quantity | 997 units |
| Distribution | US and Mexico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.