Recall Z-3183-2018 ยท FNL Bed, Ac-Powered Adjustable Hospital
Med-Mizer, Inc.
PR1000 Pivot Rehab Bed AC powered adjustable bed.
| Date | Jul 25, 2018 |
| Status | Terminated |
| Reason | Under certain conditions, when pivoting bed to the extreme left there are situations where the wire/cables may become pinched. A failure would result in the resident requiring to be transferred to a different bed until repairs can be made |
| Root cause | Device Design |
| Action | Customers were contacted via telephone on 7/25/18 to notify them of the issue and to make them aware of the correction. Customers were then mailed a notification letter along with necessary parts. |
| Quantity | 230 units |
| Distribution | The products were distributed to the following US states: AR, AZ, FL, GA, IA, ID, IL, IN, KY, ME, MI, MN, MO, NC, ND, NE, NM, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, and WI. The products were distributed to the following foreign countries: Canada, China, and Denmark. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.