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

FDA device recall Z-0240-2008 · posted 2007-07-24 · Terminated

Recall details

Recalling firm

Hill-Rom, Inc.

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.

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.

Root cause

Device Design

Status

Terminated

Product code

FIN

Quantity affected

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, Ph

Date initiated

2006-11-12

Date posted

2007-07-24

Date terminated

2010-10-22

Location

Batesville, IN