Recall Z-0240-2008 ยท FIN Tank, Holding, Dialysis
Hill-Rom, Inc.
Hill-Rom VersaCare Hospital Bed System; Models P3200 and P3201, Hill-Rom, Batesville, IN 47006
| Date | Jul 24, 2007 (initiated Nov 12, 2006) |
| Status | Terminated |
| Reason | 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 | 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 | 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, U |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.