Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores.
Recall
- Recall Number
- Z-1875-2009
- Event Number
- 52032
- Firm
- Hill-Rom Manufacturing, Inc.
- FEI Number
- 1045510
- Product Code
- IOQ
- Status
- Terminated
- Root Cause
- Equipment maintenance
- Initiated
- May 12, 2009
- Posted
- August 3, 2009
- Terminated
- April 3, 2012
- Address
- 4349 Corporate Rd, Charleston, SC, 29405-7445
Description
Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores.
The devices may emit smoke from the blower box assembly.
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 from the surface and notify Hill-Rom immediately. Facility-Owned Customers: In the next 60 days, for all facility owned Flexicair II and Flexicair MC3 Low Airloss Therapy Units, a Hill-Rom service technician will either replace the affected components in the blower assembly or deliver an equivalent substitute unit from Hill-Rom's rental fleet. If this malfunction occurs before the device is corrected or a substitute provided, do as follows: unplug the device, remove the patient from the surface, and immediately notify Hill-Rom Technical Support using the attached listing their geographical region.
Nationwide and Canada
889 units