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Terminated

Hill-Rom Affinity 4 Birthing Bed; Model P3700B, Hill-Rom, Inc., Batesville, IN 47006

FDA Recall Z-0617-2008 · Posted 2008-04-02

Recalling FirmHill-Rom, Inc.
Recall StatusTerminated
Product CodeHDD
Date Initiated2007-09-06
Date Terminated2010-10-15
Product Quantity1,796

Reason for Recall

Brake failure: The brakes may not hold or lock properly.

Firm Action

Hill-Rom notified consignees via Urgent Medical Device Correction letter dated 9/6/07. The letter instructed facilities to continue using the beds if they pass a test of the brake mechanism; and a Hill-Rom representative will contact the facility to schedule a replacement of the detent mechanism and adjustment of the casters.

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution - USA, Argentina, Australia, Bahamas, Belgium, Belize, Brazil, Canada, China, Denmark, Dominican Republic, France, Germany, Guam, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Jordan, Kenya, Malaysia, Mexico, Netherlands, Norway, Philippines, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Syria, Turkey, United Arab Emirates and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K915779AFFINITY BED MODEL 3600 SERIESHill-Rom, Inc. · 1993-02-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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