Recall Z-0583-2008 ยท KNC Table, Obstetric (And Accessories)
Hill-Rom, Inc.
Hill-Rom Affinity Three Birthing Bed, Model P3700A.
| Date | Feb 22, 2008 (initiated Nov 21, 2007) |
| Status | Terminated |
| Reason | Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the opening, as the hole/opening creates a shear point when the mechanism is activated. |
| Root cause | Device Design |
| Action | Consignees were notified of the problem via an Urgent Medical Device Correction letter dated 11/21/07. Users were informed that they would be receiving a free upgrade kit for all of their Affinity Birthing Beds. The Kit includes two plugs per bed, an insertion tool, and full written instructions. An instruction video is available at www.Hill-Rom.com. |
| Quantity | 32,379 for all model numbers |
| Distribution | Worldwide Distribution-- including USA and countries of Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Brunei, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guam, Honduras, Hong Ko |
| 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 |