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U.S. Department of Health and Human Services

Class 2 Device Recall Flexicair MC3

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 Class 2 Device Recall Flexicair MC3see related information
Date Initiated by FirmMay 12, 2009
Date PostedAugust 03, 2009
Recall Status1 Terminated 3 on April 03, 2012
Recall NumberZ-1875-2009
Recall Event ID 52032
510(K)NumberK863047 
Product Classification air therapy mattress - Product Code IOQ
ProductFlexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores.
Code Information 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.
Recalling Firm/
Manufacturer
Hill-Rom Manufacturing, Inc.
4349 Corporate Rd
Charleston SC 29405-7445
For Additional Information ContactJoe Fogel
843-740-8586
Manufacturer Reason
for Recall
The devices may emit smoke from the blower box assembly.
FDA Determined
Cause 2
Equipment maintenance
ActionUrgent 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.
Quantity in Commerce889 units
DistributionNationwide and Canada
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IOQ
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