Recall Z-1406-2017 ยท FSA Lift, Patient, Non-Ac-Powered
ErgoSafe Products, LLC (DBA) Prism Medical
A-series lift - A625 Manual Part No. 324117. Prism Medical.
| Date | Feb 28, 2017 (initiated Jan 30, 2017) |
| Status | Terminated |
| Reason | During internal cycle test at max load (625 lbs.) 2 units had straps break prematurely. |
| Root cause | Device Design |
| Action | The recalling firm called each customer on Jan 30, 2017 to review the recall and schedule a time for the firm to come to their facility to personally swap the recalled product for a new device. The FSNs were sent on Jan 31, 2017. |
| Quantity | 76 |
| Distribution | Product was distributed to MT and NV; one VA consignee. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.