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Warmer, Infant Radiant
FDA product code FMT · Class 2 · General Hospital
127
Registered devices
5,708
Adverse events
36
Recalls
92
510(k) clearances
Devices with this code
Argyle — Cardinal Health, Inc.DeRoyal — DEROYAL INDUSTRIES, INC.NuBorne Infant Warmer — INTERNATIONAL BIOMEDICAL, LTD.DeRoyal — DEROYAL INDUSTRIES, INC.Babytherm 8010 System — Drägerwerk AG & Co. KGaADeRoyal — DEROYAL INDUSTRIES, INC.Argyle — Cardinal Health, Inc.Tarry Probes — TARRY MEDICAL PRODUCTS, INC.ThermoTrace_Peripheral_5pcs — Drägerwerk AG & Co. KGaAFisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE LIMITEDAirLife™ — AirLife Finland OyTarry Probes — TARRY MEDICAL PRODUCTS, INC.Resuscitaire Radiant Warmer (RW82, RW82 VHA) — DRAEGER MEDICAL SYSTEMS, INC.SpO2 Unit(Masimo) — ATOM MEDICAL CORPORATIONAccuTemp Probe — KENTEC MEDICAL, INC.DeRoyal — DEROYAL INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.AccuTemp Probe — KENTEC MEDICAL, INC.AirLife — Carefusion Finland 320 OyHEATING ELEMENT 560W-120V — RPIHEATING ELEMENT 600W-120V — RPIAmeritus — KENTEC MEDICAL, INC.AirLife™ — AirLife Finland OyTarry Probes — TARRY MEDICAL PRODUCTS, 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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