Recall Z-0617-2008
Hill-Rom, Inc. · initiated September 6, 2007
Product
Hill-Rom Affinity 4 Birthing Bed; Model P3700B, Hill-Rom, Inc., Batesville, IN 47006
Codes / lots: All units manufactured prior to 11/20/07; all beds with serial numbers below 1232AA6856.
Reason for recall
Brake failure: The brakes may not hold or lock properly.
FDA-determined 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.
Details
- Recall number
- Z-0617-2008
- Initiated
- September 6, 2007
- Posted by FDA
- April 2, 2008
- Terminated
- October 15, 2010
- Product code
- HDD – Table, Obstetrical, Ac-Powered (And Accessories)
- Quantity
- 1,796
- 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.
- Recalling firm
- Hill-Rom, Inc., Batesville, IN