Hill-Rom Affinity Three Birthing Bed, Model P3700A.
This recall has been terminated (originally issued February 22, 2008).
- Company
- Hill-Rom, Inc.
- Recall Initiated
- November 21, 2007
- Posted
- February 22, 2008
- Terminated
- September 22, 2009
- Recall Number
- Z-0583-2008
- Quantity
- 32,379 for all model numbers
- Firm Location
- Batesville, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the opening, as the hole/opening creates a shear point when the mechanism is activated.
Distribution
Worldwide Distribution-- including USA and countries of Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Brunei, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guam, Honduras, Hong Kong, Hungary, Iceland, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Malaysia, Mexico, Morocco, The Netherlands, New Calidonia, New Zealand, Nigeria, Northern Mariana Islands, Norway, Oman, Panama, Philippines, Poland, Portugal, Qatar, Republic of Korea, Saudi Arabia, Singapore, South Korea, Romania, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguey, Venezuela, and Virgin Islands .
Lot / Code Info
All units. (**Affinity beds manufactured with serial number I290AA7395 or greater are not impacted by this correction.)
Root Cause
Device Design
Action Taken
Consignees were notified of the problem via an Urgent Medical Device Correction letter dated 11/21/07. Users were informed that they would be receiving a free upgrade kit for all of their Affinity Birthing Beds. The Kit includes two plugs per bed, an insertion tool, and full written instructions. An instruction video is available at www.Hill-Rom.com.