Reported May 28, 2014 · Terminated
ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
SCM True Air Technologies LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SCM True Air Technologies LLC · 7955 National Tpke Unit 100 · Louisville, KY · 40214-4903
Is this the product you have?
- ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
- Lot codes and dates
Serial #'s E51050650351551810050512519E9141E9150E9160E9149E9137E5107E9162E9165E9170E9147E5323E520E9171. E9149E9516E914010051507508502504501514522E9139E10099E52510052E9148E9161E511E9144E914E526E500E521E9166E530E529 & E9146
- Amount recalled
- 48 beds
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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