Recall Z-0274-2016 ยท FNL Bed, Ac-Powered Adjustable Hospital
Hill-Rom, Inc.
Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed
| Date | Nov 13, 2015 (initiated Oct 7, 2015) |
| Status | Terminated |
| Reason | Hill-Rom is voluntarily recalling the Hill-Rom 100 Low Bed due to complaints of patient injury when exiting the beds set at the lowest position setting. |
| Root cause | Device Design |
| Action | Hill-Rom initiated Phase 1 of the recall on October 2, 2015, which included notices of the recall being issued to customers via certified mail, which included safety information on how to properly use the bed, and instructions to forward the information on if devices have been transferred. Phase 2 for the recall will include the distribution of caps for the edges of the bed to be placed on by the customers. Customers may contact Hill-Rom Technical Support at 800-445-3720. |
| Quantity | 12251 units |
| Distribution | Worldwide Distribution - USA (nationwide) to the states of : AL, AR, AZ. CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV., and to the countries of : Canada and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.