Hill-Rom Affinity 4 Birthing Bed; Model P3700B, Hill-Rom, Inc., Batesville, IN 47006
This recall has been terminated (originally issued April 2, 2008).
- Company
- Hill-Rom, Inc.
- Recall Initiated
- September 6, 2007
- Posted
- April 2, 2008
- Terminated
- October 15, 2010
- Recall Number
- Z-0617-2008
- Quantity
- 1,796
- Firm Location
- Batesville, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Brake failure: The brakes may not hold or lock properly.
Distribution
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.
Lot / Code Info
All units manufactured prior to 11/20/07; all beds with serial numbers below 1232AA6856.
Root Cause
Component design/selection
Action Taken
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.