FDA-Device2014-05-28Class II
ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
SCM True Air Technologies LLC
Hazard
The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.
Sold states
Nationwide Distribution including GA, KY, and MI.
Affected count
48 beds
Manufactured in
7955 National Tpke Unit 100, N/A, Louisville, KY, United States
Products
ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1631-2014Don't want to check this manually?
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