Warmer, Infant Radiant
General Hospital · 21 CFR 880.5130
Recent MDR events
5,708 adverse event reports on file
- PandaJul 30, 2026MalfunctionDatex-ohmeda, Inc.3036470679-2026-00124
- Neontal Temperature Skin Senso, NovaPlusJul 29, 2026MalfunctionDeroyal Cientifica De Latinoamerica S.r.l9613793-2026-00010
- Lullaby WarmerJul 29, 2026MalfunctionWipro Ge Healthcare Private Ltd.9617277-2026-00001
- Giraffe IRSJul 28, 2026MalfunctionDatex-ohmeda, Inc.3036470679-2026-00120
- PandaJul 28, 2026MalfunctionDatex-ohmeda, Inc.3036470679-2026-00122
- F&P NeopuffJul 27, 2026MalfunctionFisher & Paykel Healthcare Ltd9611451-2026-02251
- F&P NeopuffJul 27, 2026MalfunctionFisher & Paykel Healthcare Ltd9611451-2026-02252
- PANDA IRES WARMERJul 22, 2026MalfunctionDatex-ohmeda, Inc.3036470679-2026-00114
- DEROYALJul 22, 2026MalfunctionDeroyal Industries, Inc.25904502
- F&P NEOPUFFJul 21, 2026MalfunctionFisher & Paykel Healthcare Ltd9611451-2026-02253
Event type breakdown
Recalls
36 recall events for this product code
- Datex-Ohmeda IncOpen, ClassifiedJun 18, 2026
Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with
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 set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
Z-2358-2026 · View FDA record ↗ - Datex-Ohmeda IncOpen, ClassifiedJun 18, 2026
Panda Freestanding Warmer, Infant Radiant Warmer
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 set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
Z-2359-2026 · View FDA record ↗ - Wipro GE Healthcare Private Ltd.Open, ClassifiedSep 20, 2024
GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to the
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 electrical safety protections included in the product design. However, because the electrical safety testing in manufacturing was incomplete for these devices, there is the potential for leakage current to exceed IEC 60601 limits.
Z-3080-2024 · View FDA record ↗ - Wipro GE Healthcare Private Ltd.Open, ClassifiedSep 20, 2024
GE Panda iRES Warmer, Model/Catalog Numbers:
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 electrical safety protections included in the product design. However, because the electrical safety testing in manufacturing was incomplete for these devices, there is the potential for leakage current to exceed IEC 60601 limits.
Z-3081-2024 · View FDA record ↗ - Draeger Medical Systems, Inc.Open, ClassifiedJun 22, 2023
Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1, RW82-1C, RW82-1D, WBR82-1 and WBR82-1C
The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.
Z-1992-2023 · View FDA record ↗ - GE Healthcare, LLCTerminatedDec 3, 2019
Giraffe OmniBed infant warmer
Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.
Z-0538-2020 · View FDA record ↗ - GE Healthcare, LLCTerminatedDec 3, 2019
Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX. infant warmer
Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.
Z-0539-2020 · View FDA record ↗ - GE Healthcare, LLCTerminatedDec 3, 2019
Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmer
Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.
Z-0540-2020 · View FDA record ↗ - GE Healthcare, LLCTerminatedDec 3, 2019
Giraffe Incubator infant warmer
Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.
Z-0541-2020 · View FDA record ↗ - GE Healthcare, LLCTerminatedJul 11, 2019
Giraffe Infant Radiant Warmer
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 or the maneuvering handle.
Z-1846-2019 · View FDA record ↗
Registered firms
104 firms currently registered for this product code
Draegerwerk Ag & Co. Kgaa
LUEBECK Schleswig-Holstein, DE
Draeger Medical Systems, Inc.
Telford, PA, US
Draegerwerk Ag & Co. Kgaa
LUEBECK Schleswig-Holstein, DE
Datex-ohmeda, Inc.
Wauwatosa, WI, US
Ad Supply Group Limited
London London, City of, GB
Datex-ohmeda, Inc.
Waukesha, WI, US
Deroyal Industries, Inc.
MAYNARDVILLE, TN, US
Atom Medical Corporation
Sakura-ku, Saitama-shi, JP
Rg Medical Usa
Mount Juliet, TN, US
Fisher & Paykel Healthcare, Inc.
IRVINE, CA, US
Ge Medical Systems Information Technologies - Critikon De Mexico S. De R.l. De C.v.
JUAREZ Chihuahua, MX
Replacement Parts Industries, Inc.
Simi Valley, CA, US
Graphic Controls Acquisition Corp.dba Nissha Medical Technologies
BUFFALO, NY, US
Sunmed Group Holdings, Llc
Grand Rapids, MI, US
Bioseal
PLACENTIA, CA, US
510(k) clearances
92 clearances for this product code
- Draeger Medical Systems, Inc.Jan 17, 2025
K243606 · Babyroo TN300
- Draeger Medical Systems, Inc.May 30, 2023
K230278 · Babyroo TN300
- Datex Ohmeda, Inc.Mar 2, 2022
K213551 · Giraffe Omnibed Carestation CS1
- GE HealthcareFeb 12, 2021
K201628 · Panda iRes Warmer, Giraffe Warmer
- Deroyal Industries, Inc.Apr 2, 2020
K200319 · HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable
- Deroyal Industries, Inc.Jan 21, 2020
K191425 · Hydro-Temp Neonatal Skin Temperature Probe Cover
- International BiomedicalAug 17, 2018
K173516 · NuBorne Infant Warmer
- Ohmeda MedicalFeb 5, 2013
K123309 · GIRAFFE AND PANDA WARMERS