Recall Z-0240-2008
Hill-Rom, Inc. · initiated November 12, 2006
Product
Hill-Rom VersaCare Hospital Bed System; Models P3200 and P3201, Hill-Rom, Batesville, IN 47006
Codes / lots: Serial numbers E322AD0046 through H023AD6179. (E means 2003 production, F means 2004 production, G means 2005 production and H means 2006 production).
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0240-2008
- Initiated
- November 12, 2006
- Posted by FDA
- July 24, 2007
- Terminated
- October 22, 2010
- Product code
- FIN – Tank, Holding, Dialysis
- Quantity
- 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.
- Recalling firm
- Hill-Rom, Inc., Batesville, IN