Recall Z-0013-2018 ยท FSA Lift, Patient, Non-Ac-Powered
Handicare Usa Inc
PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
| Date | Sep 15, 2017 (initiated Sep 8, 2017) |
| Status | Terminated |
| Reason | During internal cycle testing of A-Series lifts Handicare has found that the A-Series lift strap for lifts manufactured between April 25, 2017 and June 12, 2017 may wear prematurely at max load (625 lbs). We have identified the root cause as a supplied component that was not to specification. If the strap wears during use there is a potential risk for the person being supported by the lift to drop. |
| Root cause | Component design/selection |
| Action | The firm initiated their recall by email on 09/08/2017. The consignee was warned that the lift straps may wear prematurely and they would be contacted by a representative and the units would be replaced. |
| Quantity | 8 units |
| Distribution | Us and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.