Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores.
- Company
- Hill-Rom Manufacturing, Inc.
- Recall Initiated
- May 12, 2009
- Posted
- August 3, 2009
- Terminated
- April 3, 2012
- Recall Number
- Z-1875-2009
- Quantity
- 889 units
- Firm Location
- Charleston, SC
Reason for Recall
The devices may emit smoke from the blower box assembly.
Distribution
Nationwide and Canada
Lot / Code Info
All serial numbers. The prefix "IC" is representative of a Flexicair¿ MC3 and a six digit number without a prefix is representative of a refurbished Flexicair¿ MC3.
Root Cause
Equipment maintenance
Action Taken
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.