Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0240-2008

Hill-Rom VersaCare Hospital Bed System; Models P3200 and P3201, Hill-Rom, Batesville, IN 47006

Hill-Rom Inc. / initiated 2006-11-12 / Terminated / root cause: design

Hill-Rom, Inc. began a recall of Hill-Rom VersaCare Hospital Bed System; Models P3200 and P3201, Hill-Rom, Batesville, IN 47006 on . The reason FDA records is "False Latch/Failure to Latch-The side rail may not latch, or the latch may not fully engage, resulting in the siderail being able to be lowered without pulling on the release handle". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0240-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hill-Rom Inc.
Product
Hill-Rom VersaCare Hospital Bed System; Models P3200 and P3201, Hill-Rom, Batesville, IN 47006
Product code
FIN Tank, Holding, Dialysis
Reason for recall
False Latch/Failure to Latch-The side rail may not latch, or the latch may not fully engage, resulting in the siderail being able to be lowered without pulling on the release handle.
Root cause tag
design
FDA root cause
Device Design
Action
The firm notified consignees via an Urgent Device Correction letter dated 11/12/07 informing them of the problem and informed them they would be receiving upgrade kits which they could have their qualified personnel install themselves following video instructions also provided, or they could contact Hill-Rom for assistance.
Quantity in commerce
43,731 beds total for both models were distributed; 3,282 have been corrected to date.
Distribution
Worldwide, including USA, Argentina, Australia, Brazil, Canada, Dominican Republic, Emirate of Sharjah, England, Greece, Indonesia, Japan, Jordan, Kuwait, Lebanon, Malaysia, Mexico, Oman, Pakistan, Philippines, Qatar, Saudi Arabia, Selangor, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey, United Arab Emirates and Venezuela.
Product codes and lots
Serial numbers E322AD0046 through H023AD6179. (E means 2003 production, F means 2004 production, G means 2005 production and H means 2006 production).