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Warmer, Infant Radiant
FDA product code FMT · Class 2 · General Hospital
128
Registered devices
5,812
Adverse events
36
Recalls
92
510(k) clearances
Devices with this code
Sunflower Warmer, Wall Mount AC120V — ATOM MEDICAL CORPORATIONDeRoyal — DEROYAL INDUSTRIES, INC.HEATING ELEMENT — RPIDeRoyal — DEROYAL INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.Sunflower Warmer, Wall Mount AC120V — ATOM MEDICAL CORPORATIONDeRoyal — DEROYAL INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.Ameritus — KENTEC MEDICAL, INC.Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE LIMITEDResuscitaire Birthing Room Warmer (WBR82) — DRAEGER MEDICAL SYSTEMS, INC.DeRoyal — DEROYAL INDUSTRIES, INC.Tarry Probes — TARRY MEDICAL PRODUCTS, INC.Giraffe — Datex-Ohmeda, Inc.DeRoyal — DEROYAL INDUSTRIES, INC.Ameritus — KENTEC MEDICAL, INC.Tarry Probes — TARRY MEDICAL PRODUCTS, INC.Ameritus — KENTEC MEDICAL, INC.Giraffe — Datex-Ohmeda, Inc.TenderTrode Plus™ — GRAPHIC CONTROLS ACQUISITION CORPDeRoyal — DEROYAL INDUSTRIES, INC.Panda — Datex-Ohmeda, Inc.DeRoyal — DEROYAL INDUSTRIES, INC.
Recent 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 inten |
| 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 inten |
| 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 a |
| 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 a |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 o |
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