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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Detail

Product Description ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
Recall Number Z-1631-2014
Classification Class II
Code Info 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.
Product Distributed Qty 48 beds
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.

Event Detail

Event Id 67924
Product Type Devices
Status Ongoing
Recalling Firm SCM True Air Technologies LLC
City Louisville
State KY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-18
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including GA, KY, and MI.