Home / Recalls / SCM True Air Technologies LLC / Z-1631-2014

Z-1631-2014 Class II Terminated

Recalled by SCM True Air Technologies LLC — Louisville, KY

Recall Details

Product Type
Devices
Report Date
May 28, 2014
Initiation Date
March 18, 2014
Termination Date
June 11, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
48 beds

Product Description

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

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.

Distribution Pattern

Nationwide Distribution including GA, KY, and MI.

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.

Other recalls by SCM True Air Technologies LLC

  • Z-1630-2014 Class II — JK Bariatric Beds, True Air Technologies, Inc. (March 18, 2014)
  • Z-1632-2014 Class II — MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc (March 18, 2014)