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DeRoyal
DEROYAL INDUSTRIES, INC. · Model HNICU-02 · UDI-DI 00749756166317
10
510(k) clearances
5,708
Adverse events (17 deaths)
36
Recalls
31
Facilities
Description
HYDRO-TEMP® Cover without Foam
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-08 | Datex-Ohmeda Inc | Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration se |
| 2026-05-08 | Datex-Ohmeda Inc | Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration se |
| 2024-08-09 | Wipro GE Healthcare Private Ltd. | GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electric |
| 2024-08-09 | Wipro GE Healthcare Private Ltd. | GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electric |
| 2023-05-16 | Draeger Medical Systems, Inc. | The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values. |
| 2019-10-11 | GE Healthcare, LLC | Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential |
| 2019-10-11 | GE Healthcare, LLC | Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential |
| 2019-10-11 | GE Healthcare, LLC | Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential |
| 2019-10-11 | GE Healthcare, LLC | Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential |
| 2019-03-15 | GE Healthcare, LLC | The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if the unit is moved using the bedside panels instead of the front handle o |
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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.