Recall Z-2156-2021 ยท KNC Table, Obstetric (And Accessories)
Hill-Rom, Inc.
Affinity Four Birthing Bed-used as a birthing bed 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 Model Numbers: P3700B, P3700C, P3700D, & P3700E
| Date | May 28, 2021 |
| Status | Terminated |
| Reason | Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it could potentially cause the installed foot section to be improperly engaged onto the bed, could result in injury to the user due to a fall. |
| Root cause | Device Design |
| Action | Hill Rom Issued Urgent Medical Device Correction Subject: Affinity Four Birthing BedLift-Off Foot Section REF: MOD1331 issued on 05/28/21 to Facility Risk Manager; Facility Administrator; Facility Engineer; Vigilance Manager; Biomedical Engineering; Medical Device Liaison Officer; Distributor, stating reason for recall, health risk and action to take: Verify that the Lift-Off foot section has already been updated with the new Latch Bracket and Foot Section receivers and has adequate engagement into the receivers as noted in the graphics below. Be aware that the foot section has the potential t |
| Quantity | 1,096 Beds |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, CA, IA, MS, NC, NY, OH, PA, TX, VA and the countries of Australia, Austria, Azerbaijan, Belgium, Chile, China, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Jordan, Kuwait, Netherlands, New Zealand, Norway, Portug |
| 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 |