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Recall Observatory FDA recall evidence

Device product

ECATS E 850 Bariatric Bed, True Air Technologies, Inc.

Z-1631-2014

March 18, 2014

Class II

Product summary

Firm
SCM True Air Technologies LLC
Event
Event 67924
Status
Terminated
Classification
Class II
Quantity
48 beds
Official record key
device-enforcement:Z-1631-2014

Official wording

Reason: The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.

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.

Distribution pattern: Nationwide Distribution including GA, KY, and MI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.