ECATS E 850 Bariatric Bed — Class II medical device recall Z-1631-2014
Terminated recall by SCM True Air Technologies LLC, reported 2014-05-28, distributed nationwide. The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure
| Recall number | Z-1631-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SCM True Air Technologies LLC, Louisville, KY, United States |
| Recall initiated | 2014-03-18 |
| Classified | 2014-05-18 |
| Reported by FDA | 2014-05-28 |
| Terminated | 2018-06-11 |
| Distributed | Nationwide (US) |
| Quantity | 48 beds |
| Serial numbers | 10050, 10051, 10052, 501, 502, 503, 504, 506, 507, 508, 512, 514, 515, 518, 519, 522, E10099, E500, E510, E5107, E511, E520, E521, E525, E526 and 22 more |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1631-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.