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U.S. Department of Health and Human Services

Class 2 Device Recall ECATS E 850 Bariatric Bed

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 Class 2 Recall
ECATS E 850 Bariatric Bed
see related information
Date Posted May 19, 2014
Recall Status1 Open
Recall Number Z-1631-2014
Recall Event ID 67924
Product Classification Bariatric Bed - Product Code OSI
Product ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
Code Information Serial #'s E510, 506, 503, 515, 518, 10050, 512, 519, E9141, E9150, E9160, E9149, E9137, E5107, E9162, E9165, E9170, E9147, E5323, E520, E9171. E9149, E9516, E9140, 10051, 507, 508, 502, 504, 501, 514, 522, E9139, E10099, E525, 10052, E9148, E9161, E511, E9144, E914, E526, E500, E521, E9166, E530, E529 & E9146.
Recalling Firm/
Manufacturer
SCM True Air Technologies LLC
7955 National Tpke Unit 100
Louisville, Kentucky 40214-4903
For Additional Information Contact Mr. Daniel L. Edgeson
800-682-7163
Manufacturer Reason
for Recall
The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action SCM True Air Technologies LLC sent an Urgent Medical Device Recall letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product from use and return to True Air Technologies immediately. The units should be decontaminated and bagged with a certification of disinfection before return to True Air Technologies. True Air will provide replacement units to replace the returned units. Customers were instructed to refer to the Medical Device Recall Return Response Form attached for acknowledgement of receipt and contact information for this voluntary recall. Customers with questions should call 800-682-7163.
Quantity in Commerce 48 beds
Distribution Nationwide Distribution including GA, KY, and MI.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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