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U.S. Department of Health and Human Services

Class 2 Device Recall Flexicair II

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  Class 2 Device Recall Flexicair II see related information
Date Initiated by Firm May 12, 2009
Date Posted August 03, 2009
Recall Status1 Terminated 3 on April 03, 2012
Recall Number Z-1874-2009
Recall Event ID 52032
510(K)Number K863047  
Product Classification air therapy mattress - Product Code IOQ
Product Flexicair¿ II (model 13000) Low Airloss Therapy Units, for the prevention of pressure sores.
Code Information All serial numbers. The devices have a nomenclature for each respective product model where the serial number is IBxxxxxx, where "xxxxxx" is a six digit number. The prefix "IB" is representative of a Flexicair¿ II.
Recalling Firm/
Manufacturer		 Hill-Rom Manufacturing, Inc.
4349 Corporate Rd
Charleston SC 29405-7445
For Additional Information Contact Joe Fogel
843-740-8586
Manufacturer Reason
for Recall		 The devices may emit smoke from the blower box assembly.
FDA Determined
Cause 2		 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 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 Commerce 57 units
Distribution Nationwide and Canada
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = IOQ and Original Applicant = SSI MEDICAL SERVICES, INC.
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