Recall Z-0088-2009 ยท IOQ Bed, Flotation Therapy, Powered
Hill-Rom Manufacturing, Inc.
Envision E700 Low Airloss Therapy Surface, Made By Hill-Rom Manufacturing, Inc., Charleston, SC. The Envision E700 Low Airloss Therapy Surface helps prevent and treat stage III and stage IV pressure ulcers in patients who weigh between 70 lb and 400 lb and are between 4'11" and 6' 4" in height.
| Date | Oct 7, 2008 (initiated Jun 19, 2008) |
| Status | Terminated |
| Reason | A defect in the software of the device may not allow the patient bed exam alarm or the patient movement alarm to function correctly. |
| Root cause | Software change control |
| Action | An internal Modification Notice dated 9/1/08 was sent via email to Service Centers (because the device is owned by the manufacturer, Hill-Rom, each Service Center in possession of the device will be the consignee). Each Service Center will perform the correction on the units affected. Each device in the affected serial number range will be tested for the software defect. If the defect is found, the circuit board that contains the defective software will be replaced. The Field Action Plan is expected to be completed on July 24, 2008. Expected completion date of the Correction will be 12 months |
| Quantity | 779 units |
| Distribution | Worldwide Distribution --- including USA and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.