FDA Device recall Z-1631-2014
ECATS E 850 Bariatric Bed, True Air Technologies, Inc
- FDA Device
- Class II
- terminated
- Published 2014-05-28
On 2014-05-28 the FDA classified a Class II recall of ECATS E 850 Bariatric Bed, True Air Technologies, Inc by Scm True Air Technologies, citing the firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1631-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-18 |
| Published | 2014-05-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Scm True Air Technologies |
| Distribution | US |
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.
Identifiers
| code_info | Serial #'s E510, 506, 503, 515, 518, 10050, 512, 519, E9141, E9150, E9160, E9149, E9137, E5107, E9162, E9165, E9170, E9…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1631-2014%22
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