Z-1631-2014Class II

ECATS E 850 Bariatric Bed, True Air Technologies, Inc

Name: Z-1631-2014 ECATS E 850 Bariatric Bed, True Air Technologies, Inc
Creator: SCM True Air Technologies LLC
Published: 2014-03-18
License: https://open.fda.gov/license/

Aim Manufacturing, LLC / initiated 2014-03-18 / Terminated / root cause: manufacturing process

FDA source

SCM True Air Technologies LLC began a recall of ECATS E 850 Bariatric Bed, True Air Technologies, Inc on 2014-03-18. FDA classified it as Class II and gives the reason as "The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1631-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-18
Posted: 2014-05-19
Terminated: 2018-06-11
Recalling firm: Aim Manufacturing, LLC
Product: ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
Product code: OSI Bariatric Bed
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: SCM True Air Technologies LLC sent an Urgent Medical Device Recall letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product from use and return to True Air Technologies immediately. The units should be decontaminated and bagged with a certification of disinfection before return to True Air Technologies. True Air will provide replacement units to replace the returned units. Customers were instructed to refer to the Medical Device Recall Return Response Form attached for acknowledgement of receipt and contact information for this voluntary recall. Customers with questions should call 800-682-7163.
Quantity in commerce: 48 beds
Distribution: Nationwide Distribution including GA, KY, and MI.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1631-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1630-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-18
Z-1631-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-18
Z-1632-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-18

Product code OSI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)