Hill-Rom VersaCare Hospital Bed System; Models P3200 and P3201, Hill-Rom, Batesville, IN 47006
FDA Recall Z-0240-2008 · Posted 2007-07-24
Recalling FirmHill-Rom, Inc.
Recall StatusTerminated
Product CodeFIN
Date Initiated2006-11-12
Date Terminated2010-10-22
Product Quantity43,731 beds total for both models were distributed; 3,282 have been corrected to date.
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.