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Medical Warming Systems
R.G. ENTERPRISES (U.S.A.), INC. · Model Ultralife Battery Assembly · UDI-DI 00614801000048
DWJ
Prescription
1
510(k) clearances
26,610
Adverse events (54 deaths)
70
Recalls
88
Facilities
Description
Battery for thermal regulating systems to prevent/treat hypothermia in pre clinical settings or treatment on site. Intended for use at rescue scene, during patient transport by air or ground to medical facility. Selectable temperature ranging from 98.6F to 104F via control unit with visual and acoustic alarm systems to indicate when temperature is reached.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-13 | Gentherm Medical, LLC | Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down, |
| 2026-07-13 | Gentherm Medical, LLC | Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down. |
| 2026-07-13 | Gentherm Medical, LLC | Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down. |
| 2025-05-13 | Belmont Instrument LLC | An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1. The Human Sensor Board is disconne |
| 2024-12-16 | Augustine Temperature Management, LLC | There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the matt |
| 2024-12-16 | Augustine Temperature Management, LLC | There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the matt |
| 2024-12-16 | Augustine Temperature Management, LLC | There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the matt |
| 2024-12-04 | Augustine Temperature Management, LLC | Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test |
| 2024-12-04 | Augustine Temperature Management, LLC | Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test |
| 2024-12-04 | Augustine Temperature Management, LLC | Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test |
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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.