High FDA (Devices)·Z-2156-2021·Announced 2021-08-04

Affinity Four Birthing Bed Latch Mechanism Defect Poses Fall Risk

The latch mechanism on the Lift-Off foot section of certain Affinity Four Birthing Beds may be damaged, potentially causing improper engagement and creating a fall risk for patients. Hill-Rom is recalling approximately 1,096 affected beds.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a potential mechanical failure of a critical safety feature on medical equipment. Although no injuries have been reported, the defective latch mechanism creates a clear risk of falls for vulnerable patients during labor and delivery.

Plain-English summary

Hill-Rom, Inc. is recalling Affinity Four Birthing Beds (Models P3700B, P3700C, P3700D, and P3700E). The latch mechanism on the Lift-Off foot section may be damaged on certain units.

A damaged latch mechanism could cause the installed foot section to become improperly engaged onto the bed. This could result in the foot section disengaging during use, creating a fall risk for patients.

These beds are used in Labor, Delivery, Recovery (LDR) and Labor, Delivery, Recovery, Postpartum (LDRP) settings in acute care hospitals. Approximately 1,096 beds have been distributed worldwide, including throughout the United States (Alabama, California, Iowa, Mississippi, North Carolina, New York, Ohio, Pennsylvania, Texas, and Virginia) and internationally.

The recalled product

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
Manufacturer: Hill-Rom, Inc.
Category: Medical Device — Hospital Birthing Bed
Hazard: latch-failure
fall-risk
Affected units: 1,096

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Same manufacturer · Hill-Rom, Inc.

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Same hazard · latch failure