Recall Z-2082-2012
Hill-Rom, Inc. · initiated April 2, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery ) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market. They are not intended for use as general hospital beds.
Codes / lots: Affinity Four Birthing Beds (P3700) manufactured with Serial Numbers H331AA4785 thru N081AA7966
Reason for recall
During review of our last braking system via that field corrective action, the system still did not meet our expectations, which is to eliminate the hazards of patient falling. Bed movement immediately prior to, or during the birthing process may still create distractions and delays, resulting in patient or caregiver falls, or contribute to a deviation in a procedure, (e.g. IV insertion, epidural
FDA-determined cause: Device Design
Action taken
Hill-Rom sent an URGENT FIELD SAFETY NOTICE letter dated April 2, 2012 to all affected customers. The letter identified the affected products, problem and actions to be taken. Customers were informed that Hill-Rom will visit their facility to modify the affected products, however, until then follow the actions to be taken outlined. For questions concerning this request or the procedure as outlined contact Hill-Rom Technical Support at 800-445-3720 (U.S.).
Details
- Recall number
- Z-2082-2012
- Initiated
- April 2, 2012
- Posted by FDA
- July 26, 2012
- Terminated
- July 21, 2015
- Product code
- KNC – Table, Obstetric (And Accessories)
- Quantity
- 12,726 devices
- Distribution
- Worldwide Distribution - US Nationwide and countries including: Argentina , Aruba, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Brunei, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guam, Guyana, Hong Kong, Hungary, India, Indonesia, Iraq…
- Recalling firm
- Hill-Rom, Inc., Batesville, IN