Hill-Rom Affinity Four Birthing Bed, Hill-Rom Company, Inc., Batesville, Indiana; Model P3700B. Intended to be used as birthing beds for momen of child bearing age in an labor, delivery, recovery or postpartum setting in acute care.
FDA Recall Z-0548-2010 · Posted 2009-12-17
Recalling FirmHill-Rom, Inc.
Recall StatusTerminated
Product CodeHDD
Date Initiated2009-11-16
Date Terminated2012-07-02
Product Quantity2551 (US), 4171 (OUS)
Reason for Recall
The brakes may not hold or lock.
Firm Action
Hill-Rom issued an "Urgent Safety Notice" notification dated November 16, 2009 to customers. The letter advised users of the problem and asking them to locate the beds and to remove them from use until corrected if possible and, if not possible to inspect them for the problem and remove them from use if it is present. The firm will visit each account to make corrections.
For further information, contact Hill-Rom Technical Support at 1-800-445-3720.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution -- United States, Canada, Argentina, Australia, Bahamas, Brazil, Chile, China, Denmark, Dominican Republic, France, Great Britain, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Libiya, Netherlands, Poland, Puerto Rico, Russia, Saudi Arabia, Serbia, Singapore, Spain, Sweden, Syria, Thailand, Turkey and United Arab Emirates.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.