Recall Z-0617-2008 ยท HDD Table, Obstetrical, Ac-Powered (And Accessories)
Hill-Rom, Inc.
Hill-Rom Affinity 4 Birthing Bed; Model P3700B, Hill-Rom, Inc., Batesville, IN 47006
| Date | Apr 2, 2008 (initiated Sep 6, 2007) |
| Status | Terminated |
| Reason | Brake failure: The brakes may not hold or lock properly. |
| Root cause | Component design/selection |
| Action | Hill-Rom notified consignees via Urgent Medical Device Correction letter dated 9/6/07. The letter instructed facilities to continue using the beds if they pass a test of the brake mechanism; and a Hill-Rom representative will contact the facility to schedule a replacement of the detent mechanism and adjustment of the casters. |
| Quantity | 1,796 |
| Distribution | Worldwide Distribution - USA, Argentina, Australia, Bahamas, Belgium, Belize, Brazil, Canada, China, Denmark, Dominican Republic, France, Germany, Guam, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Jordan, Kenya, Malaysia, Mexico, Netherlands, Norway, Philippines, Russia, Saudi Arabia, Sin |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915779 | AFFINITY BED MODEL 3600 SERIES Hill-Rom, Inc., Feb 24, 1993 |