Recall Z-2562-2014— Hill-Rom, Inc.

Name: FDA recall Z-2562-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-26

Class II · Terminated

Class II FDA medical device recall by Hill-Rom, Inc., initiated 2014-06-26, terminated 2017-07-14. It names one FDA 510(k) clearance: K915779. Product: 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.. 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..

Recalling firm: Hill-Rom, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-06-26
Terminated: 2017-07-14
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, 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.

Reason for recall

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.

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