Recall Z-2156-2021— Hill-Rom, Inc.

Name: FDA recall Z-2156-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-28

Class II · Terminated

Class II FDA medical device recall by Hill-Rom, Inc., initiated 2021-05-28, terminated 2024-06-06. It names one FDA 510(k) clearance: K915779. Product: 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. 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..

Recalling firm: Hill-Rom, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-05-28
Terminated: 2024-06-06
Firm location: Batesville, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K915779 — AFFINITY BED MODEL 3600 SERIESHill-Rom, Inc.·cleared 1993-02-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.