Home / Recalls / SCM True Air Technologies LLC / Z-1630-2014

Z-1630-2014 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
24 beds

Product Description

JK Bariatric Beds, 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 41160, 10127, 09504, 41918, 106800, 62188, 106805, 42331, 106751, 00234A, 62422, 7987, 50147, 7111, 11151100, BB111, 00284A, 2171269, 62383, 4731, 4732, 4733, 4734, 4735

Other recalls by SCM True Air Technologies LLC

  • Z-1632-2014 Class II — MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc (March 18, 2014)
  • Z-1631-2014 Class II — ECATS E 850 Bariatric Bed, True Air Technologies, Inc. (March 18, 2014)