Recall Z-1631-2014— SCM True Air Technologies LLC

Name: FDA recall Z-1631-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-18

Class II · Terminated

Class II FDA medical device recall by SCM True Air Technologies LLC, initiated 2014-03-18, terminated 2018-06-11. FDA's recall record names no specific 510(k) clearance for this event. Product: ECATS E 850 Bariatric Bed, True Air Technologies, Inc.. 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..

Recalling firm: SCM True Air Technologies LLC
Classification: Class II
Status: Terminated
Initiated: 2014-03-18
Terminated: 2018-06-11
Firm location: Louisville, KY, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.