Recall Z-0548-2010 ยท HDD Table, Obstetrical, Ac-Powered (And Accessories)
Hill-Rom, Inc.
Hill-Rom Affinity Four Birthing Bed, Hill-Rom Company, Inc., Batesville, Indiana; Model P3700B. Intended to be used as birthing beds for momen of child bearing age in an labor, delivery, recovery or postpartum setting in acute care.
| Date | Dec 17, 2009 (initiated Nov 16, 2009) |
| Status | Terminated |
| Reason | The brakes may not hold or lock. |
| Root cause | Device Design |
| Action | Hill-Rom issued an "Urgent Safety Notice" notification dated November 16, 2009 to customers. The letter advised users of the problem and asking them to locate the beds and to remove them from use until corrected if possible and, if not possible to inspect them for the problem and remove them from use if it is present. The firm will visit each account to make corrections. For further information, contact Hill-Rom Technical Support at 1-800-445-3720. |
| Quantity | 2551 (US), 4171 (OUS) |
| Distribution | Worldwide Distribution -- United States, Canada, Argentina, Australia, Bahamas, Brazil, Chile, China, Denmark, Dominican Republic, France, Great Britain, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Libiya, Netherlands, Poland, Puerto Rico, Russia, Saudi Arabia, Serbia, |
| 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 |