SCM True Air Technologies Recalls ECATS E 850 Bariatric Beds
SCM True Air Technologies is recalling 48 ECATS E 850 Bariatric Beds due to manufacturing documentation and vendor approval failures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text cites documentation and vendor approval failures without reporting any injuries, illnesses, or specific mechanical hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
SCM True Air Technologies LLC is recalling 48 units of the ECATS E 850 Bariatric Bed. The recall was initiated by the U.S. Food and Drug Administration (FDA) and is classified as a Class II 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. These are quality control and documentation issues rather than reported mechanical failures or injuries.
The affected beds were distributed nationwide, including in Georgia, Kentucky, and Michigan. Consumers and healthcare facilities should check their serial numbers against the list provided by the FDA and contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
- Manufacturer
- SCM True Air Technologies LLC
- Category
- Medical Device — Hospital Bed
- Affected units
- 48
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial #'s E510
- 506
- 503
- 515
- 518
- 10050
- 512
- 519
- E9141
- E9150
- E9160
- E9149
- E9137
- E5107
- E9162
- E9165
- E9170
- E9147
- E5323
- E520
Distribution
Part of a larger recall action
This product is one of 3 recalled by SCM True Air Technologies LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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