Recall Z-2562-2014 ยท KNC Table, Obstetric (And Accessories)
Hill-Rom, Inc.
Affinity Four Birthing Bed, Product Usage: Product is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market.
| Date | Sep 1, 2014 (initiated Jun 26, 2014) |
| Status | Terminated |
| Reason | The attachment latch mechanism can become bent depending on user handling. Latch mechanism bending could lead to improper engagement of the foot section and this could result in injury to the user due to a fall. |
| Root cause | Nonconforming Material/Component |
| Action | Hill-rom issued an Urgent Field Safety Notice letter dated June 26, 2014 to affected customers. The Notification identified the affected product issue and instructions for product inspection. The letter states that the firm is working on making changes to the Lift-Off foot section that will mitigate risk even if damage was to occur. If you have any questions concerning the notice or requested procedure, please contact Hill-Rom Technical Support at 800-445-3720. |
| Quantity | 13,000 units |
| Distribution | Worldwide Distribution - US Nationwide and the following countries: Argentina , Aruba, Australia, Austria, Bahamas, Bahrain, Belgium, Belize, Bermuda, Brazil, Brunei, Bulgaria, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Eg |
| 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 |