Recall Z-0761-04 ยท LLI Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
Hill-Rom, Inc.
Hill-Rom brand TotalCare bed system; model P1900 -remanufactured only.
| Date | Jul 20, 2004 (initiated Mar 15, 2004) |
| Status | Terminated |
| Reason | A warning label, advising users not to use oxygen tents with this equipment because of the potential for a fire, was not placed on these remanufactured beds. |
| Root cause | Other |
| Action | A letter dated 3/15/04 was sent to each affected consignee, with labels included, requesting that they attach them to each affected bed. |
| Quantity | 52 |
| Distribution | Arizona, Florida, Georgia, Nevada, Puerto Rico, Texas, Virginia and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.