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ThermalX
ADROIT MEDICAL SYSTEMS, INC. · Model 961 · UDI-DI 10615089702201
5
510(k) clearances
7
Adverse events (1 deaths)
1
Recalls
237
Facilities
Description
Large Kit: Contains (1) Adult Cap and (1) Large Blanket
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-12-23 | Encompass Group LLC | The products are not compatible for use in the Magnetic Resonance Imaging (MRI) environment. |
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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.