Recall Z-0058-04 ยท IOQ Bed, Flotation Therapy, Powered
Hill-Rom Manufacturing, Inc.
FLEXICAIR II, Low Airloss Therapy unit.This unit is similar to MC3 but does not have the utility shelf above the foodboard, patient scale or alternate CPR function actuators.
| Date | Oct 24, 2003 (initiated Aug 27, 2003) |
| Status | Terminated |
| Reason | Reports of patient entrapment between mattress and side-rails. |
| Root cause | Other |
| Action | Consignees were notified by letter on 08/27/2003. They were alerted to the potential for patient entrapment. Modification of the units were to be conducted at the rental service center, or the sight where the unit is currently located. The consignee would be contacted to arrange for the modification to be installed on the rental if it is at their location when the modification is scheduled for the unit. If the consignee purchased the bed, they would be contacted by a Hill Rom service representative to arrange to install the modification.Enclosed with the letter is information regarding, Tip |
| Quantity | 515 units |
| Distribution | Product is distributed through rental and sale nationwide, Canada, Austria, Germany and the U.K. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K863047 | FLEXICAIR Ssi Medical Services, Inc., Sep 5, 1986 |