Recall Z-1874-2009 ยท IOQ Bed, Flotation Therapy, Powered
Hill-Rom Manufacturing, Inc.
Flexicair II (model 13000) Low Airloss Therapy Units, for the prevention of pressure sores.
| Date | Aug 3, 2009 (initiated May 12, 2009) |
| Status | Terminated |
| Reason | The devices may emit smoke from the blower box assembly. |
| Root cause | Equipment maintenance |
| Action | Urgent Field Safety Notice letter dated May 11, 2009. Hill-Rom service centers were notified by letter on 05/13/2009. Action to be taken are as follows: Rental Customers; In the next 60 days, Hill Rom will be removing the Flexicair II and Flexicair MC3 low Airloss Therapy Units from service to correct the devices. During that time, Hill-Rom may provide an equivalent substitute therapy to accommodate the patients who continue to need a pressure reducing therapy device. If t his malfunction occurs before a substitution or a corrected device is provided, unplug the device, remove the patient fr |
| Quantity | 57 units |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K863047 | FLEXICAIR Ssi Medical Services, Inc., Sep 5, 1986 |