Recall Z-1204-2023 ยท FSA Lift, Patient, Non-Ac-Powered
Med-Mizer, Inc.
Med-Riser MR600 Patient Lift
| Date | Mar 2, 2023 (initiated Feb 3, 2023) |
| Status | Open, Classified |
| Reason | Risk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be unsecure to the flange on the side. |
| Root cause | Device Design |
| Action | Med-Mizer notified distributors of this recall event by distributing an Urgent Medical Device Recall Notice on 02/03/2022 via Certified Mail. The MR600 and STS500 Patient Lifts are being subject to recall due to the potential for the nut securing the boom to become loose over time, which could result in the boom moving unexpectedly side to side or dropping the patient during operation. Customers are asked to inspect all affected devices at their facility to determine if the nut securing the boom is loose. If it is, immediately remove the device from service. Med-Mizer is providing customers wi |
| Quantity | 241 units |
| Distribution | Awaiting consignee list from the recalling firm. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.