Recall Z-1595-2024 ยท FNG Lift, Patient, Ac-Powered
Raye's Inc.
SW Bari Lift & Transfer, Model Number 38060000
| Date | Apr 18, 2024 (initiated Jan 25, 2024) |
| Status | Open, Classified |
| Reason | Retrospective engineering analysis against current ISO standards for hoists has determined: 1. The device cannot physically perform at maximum documented weight specifications when a factor of safety of two times the maximum load is applied. 2. The device is not equipped with a safety device to ensure a person with disability would not fall in the event of a single-fault condition of the lifting device. |
| Root cause | Device Design |
| Action | Sizewise Manufacturing issued an URGENT Voluntary Medical Device Recall to its consignees on 01/29/2024 by letter. The notice explained the issue, potential risk, and requested the discontinuation of use and disposal of the device. The firm sent a follow-up notice on 03/07/2024 asking the distributors to further notify their customers (users of the device). |
| Quantity | 1,149 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.