SCM True Air Technologies LLC: Medical Device Recall in 2014 - (Recall #: Z-1631-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 18, 2014

Date Posted: May 28, 2014

Recall Number: Z-1631-2014

Event ID: 67924

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.

Status: Terminated

Product Quantity: 48 beds

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.

Voluntary or Mandated:

Voluntary: Firm initiated