Recall Z-1466-2013 ยท FNL Bed, Ac-Powered Adjustable Hospital
Hill-Rom, Inc.
Hill-Rom 1000 Bed, Product No. P1160. The Hill-Rom 1000 Bed is intended for low to moderate acuity patient in the medical surgical area of the hospital.
| Date | Jun 5, 2013 (initiated Apr 15, 2013) |
| Status | Terminated |
| Reason | Complaints have been reported for brakes disengaging when the bed is subjected to a hard jolt or force to the frame. |
| Root cause | Process control |
| Action | On 4/16/2013 an URGENT MEDICAL DEVICE CORRECTION notification letter was sent to all consignees. The firm plans a visit to all facilities to correct each bed. Call Hill-Rom Technical Support at 800-445-3720 if you have any questions. |
| Quantity | 8,737 devices |
| Distribution | Worldwide distribution: US (Nationwide) and countries of: Argentina , Bahamas, Bahrain, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, Egypt, Ethiopia, France, Ghana, Guam, Hong Kong, India, Indonesia, Japan, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, N. Mariana Islands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.