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Umano Medical Inc · Model USTCGS-843607XN-BIL · UDI-DI 00670482000265
10
510(k) clearances
1,182
Adverse events (42 deaths)
35
Recalls
25
Facilities
Description
LAL Cover System
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-25 | Baxter Healthcare Corporation | The air bladders inside the mattress may move out of position when the head of the bed is elevated, causing a dip in the mattress. |
| 2024-05-08 | Baxter Healthcare Corporation | There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning a |
| 2024-03-05 | Baxter Healthcare Corporation | Inconsistencies were identified with service records associated with corrections performed for a previous Medical Device Correction issued by Baxter (ref number: FA-2022-026). Your |
| 2023-10-04 | Baxter Healthcare Corporation | Progressa+ beds have the potential for static buildup from the casters and/or power drive. This static electricity could be passed to the operator through the transport handle duri |
| 2023-03-31 | Baxter Healthcare Corporation | There is a potential for mattress cover damage (delamination) which may result in fluid absorption in the mattress (fluid ingress). |
| 2022-06-24 | Baxter Healthcare Corporation | The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient res |
| 2022-06-24 | Baxter Healthcare Corporation | The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient res |
| 2022-06-24 | Baxter Healthcare Corporation | The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient res |
| 2022-06-24 | Baxter Healthcare Corporation | The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient res |
| 2022-06-24 | Baxter Healthcare Corporation | The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient res |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.