Warmer, Infant Radiant
FDA product code FMT · Class II (moderate risk) · 21 CFR 880.5130 · General Hospital
92510(k) clearances
0PMA approvals
36recalls
Manufacturers
- Ohmeda Medical 10
- Contour Medical Technology, Inc. 6
- Air-Shields, Inc. 5
- Hill-Rom, Inc. 4
- Gempco, Inc. 4
- Atom Medical Corporation 4
- Fisher & Paykel Electronics , Ltd. 4
- Draeger Medical Systems, Inc. 3
- Ohio Medical Products 3
- DeRoyal Industries Inc 3
- Kentec Medical, Inc 2
- Drager, Inc. 2
- Cas Medical Systems, Inc. 2
- Astral, Ltd. 2
- Replacement Parts Industries, Inc. 2
- Aragona Medical, Inc. 2
- Ohmeda Medical, A Division of Datex-Ohmeda, Inc. 2
- Borning Corp. 1
- Vickers America Medical Corp. 1
- Datex-Ohmeda, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243606 | Babyroo TN300FMT · Traditional | Draeger Medical Systems, Inc. | 01/17/2025SE |
| K230278 | Babyroo TN300FMT · Traditional | Draeger Medical Systems, Inc. | 05/30/2023SE |
| K213551 | Giraffe Omnibed Carestation CS1FMT · Traditional | Datex Ohmeda, Inc. | 03/02/2022SE |
| K201628 | Panda iRes Warmer, Giraffe WarmerFMT · Traditional | GE Healthcare | 02/12/2021SE |
| K200319 | HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface…FMT · Traditional | Deroyal Industries, Inc. | 04/02/2020SE |
| K191425 | Hydro-Temp Neonatal Skin Temperature Probe CoverFMT · Traditional | Deroyal Industries, Inc. | 01/21/2020SE |
| K173516 | NuBorne Infant WarmerFMT · Abbreviated | International Biomedical | 08/17/2018SE |
| K123309 | Giraffe and Panda WarmersFMT · Traditional | Ohmeda Medical | 02/05/2013SE |
| K120642 | Resuscitaire with AutobreathFMT · Traditional | Draeger Medical Systems, Inc. | 11/02/2012SE |
| K122267 | Giraffe and Panda WarmersFMT · Special | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 10/02/2012SE |
| K121625 | Lullaby TM WarmerFMT · Traditional | Wipro GE Healthcare Private, Ltd. | 09/14/2012SE |
| K120937 | Sunflower WarnerFMT · Traditional | Atom Medical Corporation | 07/06/2012SE |
| K102227 | Infa Warmer IFMT · Traditional | Atom Medical Corporation | 01/21/2011SE |
| K101804 | Giraffe and Panda WarmersFMT · Special | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 07/21/2010SE |
| K090697 | Modification to: Giraffe and Panda WarmerFMT · Special | Ohmeda Medical | 04/16/2009SE |
| K072157 | Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)FMT · Special | Ohmeda Medical | 08/27/2007SE |
| K070377 | Giraffe and Panda WarmerFMT · Traditional | Ohmeda Medical | 07/11/2007SE |
| K060461 | V-505 Infa WarmerFMT · Special | Atom Medical, Inc. | 04/28/2006SE |
| K033040 | Phoenix Infant Radiant Warmer, Model 100NWSFMT · Abbreviated | International Hospital Supply Co. | 12/17/2003SE |
| K020966 | Rpi Replacement Heating ElementsFMT · Traditional | Replacement Parts Industries, Inc. | 06/13/2002SE |
| K020219 | Rpi Skin or Air Temperature ProbeFMT · Traditional | Replacement Parts Industries, Inc. | 04/12/2002SE |
| K012229 | Scale-Tronix 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C &…FMT · Traditional | National Custom Ent., Inc. | 09/10/2001SE |
| K003335 | Resuscitaire Radiant Warmer; Resuscitaire Birthing Room Warmer; Resuscitair Wall Mounted…FMT · Special | Hill-Rom Air-Shields | 11/17/2000SE |
| K002355 | Atom Infa Warmer V-505FMT · Abbreviated | Atom Medical Corp | 10/10/2000SE |
| K971366 | IncuwarmerFMT · Traditional | Hill-Rom, Inc. | 01/05/1998SE |
| K972885 | Servo-Control Wall-Mount Cosycot Infant Warmer Model IW960, Manual Control Wall-Mount…FMT · Traditional | Fisher & Paykel Electronics , Ltd. | 10/30/1997SE |
| K971198 | Babytherm 8004 Babytherm 8010FMT · Traditional | Drager, Inc. | 10/03/1997SE |
| K970686 | Accutemp-ProbeFMT · Traditional | Kentec Medical, Inc. | 08/25/1997SE |
| K971695 | Servo-Control Cosycot Infant Warmer, Manual-Control Cosycot Infant WarmerFMT · Traditional | Fisher & Paykel Electronics , Ltd. | 07/28/1997SE |
| K971461 | Servo-Control Wall-Mount Infant WARMER(IW980)/MANUAL-CONTROL Wall-Mount Infant…FMT · Traditional | Fisher & Paykel Electronics , Ltd. | 07/16/1997SE |
| K970432 | Infant Radiant Warmer - Models IW910 and IW920FMT · Traditional | Fisher & Paykel Electronics , Ltd. | 05/07/1997SE |
| K970074 | Stanilet Freestanding/Cc INFANT/2000C Infant Warmer (1250C/1500C/2000D)FMT · Traditional | Hill-Rom, Inc. | 04/03/1997SE |
| K964401 | Kendall-Ltp Disposable Temperature Probes (DTP1,DTP2,DTP3,DTP4)FMT · Traditional | Ludlow Technical Products | 02/06/1997SE |
| K950422 | First Touch Disposables Temperature ProbesFMT · Traditional | First Touch Disposables, Inc. | 01/23/1997SE |
| K963058 | Infant Warmer SystemFMT · Traditional | Ohmeda Medical | 10/01/1996SE |
| K960080 | Accutemp ProbeFMT · Traditional | Kentec Medical, Inc. | 05/01/1996SE |
| K952807 | Temperature PROBE-TP650FMT · Traditional | Contour Medical Technology, Inc. | 04/04/1996SE |
| K952805 | Temperature PROBE-TP550FMT · Traditional | Contour Medical Technology, Inc. | 04/04/1996SE |
| K952804 | Temperature PROBE-TP450FMT · Traditional | Contour Medical Technology, Inc. | 04/04/1996SE |
| K952803 | Temperature PROBE-TP350FMT · Traditional | Contour Medical Technology, Inc. | 04/04/1996SE |
| K952801 | Temperature PROBE-TP250FMT · Traditional | Contour Medical Technology, Inc. | 04/04/1996SE |
| K952800 | Temperature PROBE-TP150FMT · Traditional | Contour Medical Technology, Inc. | 04/04/1996SE |
| K953489 | Drager Infant Radiant Warmern RH600FMT · Traditional | Drager, Inc. | 02/09/1996SE |
| K950143 | Astral Disposable Skin Temperature ProbeFMT · Traditional | Astral, Ltd. | 09/25/1995SE |
| K946005 | Astral Disposable Skin Temperature ProbeFMT · Traditional | Astral, Ltd. | 09/25/1995SE |
| K940951 | RW Resucitaire Infant Radiant WarmerFMT · Traditional | Air-Shields, Inc. | 05/03/1995SE |
| K942905 | Disposable Temperature Probe CoverFMT · Traditional | Arbo Medical, Inc. | 02/27/1995SE |
| K942904 | StabiletFMT · Traditional | Hill-Rom, Inc. | 09/16/1994SE |
| K934677 | U. S. Medical PS-3500 Warmer/Incubator ScaleFMT · Traditional | U.S. Medical Corp. | 07/05/1994SE |
| K935609 | 4002 Infant Scale for Incubators and WarmersFMT · Traditional | Scale-Tronix, Inc. | 07/01/1994SE |
| K931529 | Infant WarmerFMT · Traditional | Medix I.C.S.A. | 03/11/1994SE |
| K926030 | Klear-TempFMT · Traditional | Cas Medical Systems, Inc. | 02/24/1994SE |
| K925006 | Hydro-Temp Nicu and Skin Surface Temperature SensoFMT · Traditional | Deroyal Industries, Inc. | 01/31/1994SE |
| K921547 | AdvantageFMT · Traditional | Kci | 07/23/1993SE |
| K921766 | Ohio Infant Warmer SystemFMT · Traditional | Ohmeda Medical | 04/23/1993SE |
| K912921 | Vsi 1000FMT · Traditional | Vitaltrends Technology, Inc. | 10/30/1992SE |
| K915831 | Thermal Probe CoverFMT · Traditional | Vermont Medical, Inc. | 06/08/1992SE |
| K913945 | Stabilet Infant Radiant Warmer Model 2000CFMT · Traditional | Hill-Rom, Inc. | 02/12/1992SE |
| K910915 | Patient Warmer Model 100CFMT · Traditional | Developmed Corp. | 07/16/1991SE |
| K885350 | Preemicare Series 2000 Infant WarmerFMT · Traditional | Preemicare Corp. | 08/07/1989SE |
| K884285 | Model WC-115 Mobile BassinetFMT · Traditional | Gempco, Inc. | 12/22/1988SE |
| K884283 | Model WC-107 Mobile Newborn BedFMT · Traditional | Gempco, Inc. | 12/22/1988SE |
| K884280 | Model WC-102 Newborn Bed & Equipment CabinetFMT · Traditional | Gempco, Inc. | 12/22/1988SE |
| K881670 | Accutemp PlusFMT · Traditional | Sentry Medical Products, Inc. | 11/22/1988SE |
| K884160 | Ohmeda - Ohio(R) 3500 Infant Warmer SystemFMT · Traditional | Ohmeda Medical | 11/21/1988SE |
| K881713 | Special Procedures Base Unit Model 500FMT · Traditional | Gempco, Inc. | 07/12/1988SE |
| K875270 | Infant Intensive Care System Vertical Height AdjusFMT · Traditional | Air-Shields, Inc. | 01/19/1988SE |
| K872742 | Warm Weigh Models I-20/W-30 Infant ScaleFMT · Traditional | Air-Shields, Inc. | 10/20/1987SE |
| K871178 | MTC Xi UlFMT · Traditional | Aragona Medical, Inc. | 10/09/1987SE |
| K871177 | NTH 101 UlFMT · Traditional | Aragona Medical, Inc. | 10/09/1987SE |
| K871594 | Birthing Room WarmerFMT · Traditional | Air-Shields, Inc. | 06/05/1987SE |
| K862921 | Model 10200 Premature Infant IncubatorFMT · Traditional | Rotem Industries C/O Medsys, Inc. | 04/01/1987SE |
| K865012 | Ysi Model 801FMT · Traditional | Yellow Springs Instrument Co., Inc. | 03/04/1987SE |
| K863208 | Ohmeda Auxiliary Power SystemFMT · Traditional | Ohmeda Medical | 10/03/1986SE |
| K861781 | Delivery Room WarmerFMT · Traditional | Air-Shields, Inc. | 07/15/1986SE |
| K853926 | Neocare Model 800 Infant Radiant WarmerFMT · Traditional | Draeger Medical, Inc. | 02/26/1986SE |
| K852943 | Neo ShieldFMT · Traditional | Gaymar Industries, Inc. | 11/08/1985SE |
| K853351 | Ohmeda Heat Reflecting PatchFMT · Traditional | Ohmeda Medical | 10/17/1985SE |
| K853794 | Neoguard ReflectorFMT · Traditional | Cas Medical Systems, Inc. | 10/16/1985SE |
| K851449 | Ohmeda 5000 Infant Warmer SystemFMT · Traditional | Ohmeda Medical | 06/07/1985SE |
| K850069 | Borning Neonatal Resuscitatoin CenterFMT · Traditional | Borning Corp. | 05/30/1985SE |
| K840792 | Infant Radiant WarmerFMT · Traditional | Hatch Bio Medical | 05/25/1984SE |
| K833802 | Infant WarmerFMT · Traditional | Kinetic Concepts, Inc. | 04/05/1984SE |
| K840858 | Ohio 3300 Infant Warmer SystemFMT · Traditional | Ohio Medical Products | 03/23/1984SE |
| K840857 | Ohio 3000 Infant Warmer SystemFMT · Traditional | Ohio Medical Products | 03/23/1984SE |
| K832637 | Ameda Neonatal Resuscitation Unit-FMT · Traditional | Egnell, Inc. | 12/22/1983SE |
| K830748 | ResuscitaireFMT · Traditional | Vickers America Medical Corp. | 06/22/1983SE |
| K813408 | Sage 2200 Sterile Specimen ContainerFMT · Traditional | Sage Products, Inc. | 01/25/1982SE |
| K812745 | Warming Listhts #96H & 96HTFMT · Traditional | J. H. Emerson Co. | 11/02/1981SE |
| K802365 | Ohio Radiant WarmerFMT · Traditional | Ohio Medical Products | 10/23/1980SE |
| K790948 | Temp-Guard TMFMT · Traditional | Gordon Consultants, Inc. | 09/24/1979SE |
| K790137 | Infant Care SystemFMT · Traditional | Narco Air-Shields | 03/06/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2359-2026 Class I | Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001…Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver… | Datex-Ohmeda Inc | 05/08/2026Open, Classified |
| Z-2358-2026 Class I | Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated…Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver… | Datex-Ohmeda Inc | 05/08/2026Open, Classified |
| Z-3081-2024 Class II | GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579…GE HealthCare has become aware that complete electrical safety testing was not conducted during… | Wipro GE Healthcare Private Ltd. | 08/09/2024Open, Classified |
| Z-3080-2024 Class II | GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers…GE HealthCare has become aware that complete electrical safety testing was not conducted during… | Wipro GE Healthcare Private Ltd. | 08/09/2024Open, Classified |
| Z-1992-2023 Class II | Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s):…The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values. | Draeger Medical Systems, Inc. | 05/16/2023Open, Classified |
| Z-0541-2020 Class I | Giraffe Incubator infant warmerGiraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside… | GE Healthcare, LLC | 10/11/2019Terminated |
| Z-0540-2020 Class I | Giraffe Incubator Carestation, Giraffe Incubator Carestation CS1 infant warmerGiraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside… | GE Healthcare, LLC | 10/11/2019Terminated |
| Z-0539-2020 Class I | Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed…Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside… | GE Healthcare, LLC | 10/11/2019Terminated |
| Z-0538-2020 Class I | Giraffe OmniBed infant warmerGiraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside… | GE Healthcare, LLC | 10/11/2019Terminated |
| Z-1847-2019 Class I | Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled…The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if… | GE Healthcare, LLC | 03/15/2019Terminated |
| Z-1846-2019 Class I | Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a…The bedside panels and latch areas on the Giraffe Bedded Warmer and Panda iRes Warmer can crack or break if… | GE Healthcare, LLC | 03/15/2019Terminated |
| Z-0484-2019 Class II | Panda Wall Mount warmer. Infant radiant warmerPotential electric leakage affecting the user. | GE Healthcare, LLC | 09/25/2018Terminated |
| Z-0483-2019 Class II | Panda Freestanding Warmer. Device sold under the following product names: Panda…Potential electric leakage affecting the user. | GE Healthcare, LLC | 09/25/2018Terminated |
| Z-0482-2019 Class II | Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda…Potential electric leakage affecting the user. | GE Healthcare, LLC | 09/25/2018Terminated |
| Z-0481-2019 Class II | Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and…Potential electric leakage affecting the user. | GE Healthcare, LLC | 09/25/2018Terminated |
| Z-2323-2017 Class II | Infant Warmer System (IWS)GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater… | GE Healthcare, LLC | 05/05/2017Terminated |
| Z-1511-2017 Class II | IWS Infant Warmer System-Infant radiant warmers provide infrared heat, in a controlled…Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are… | Ohmeda Medical | 11/18/2016Terminated |
| Z-1508-2017 Class II | Giraffe Bedded Warmer, Panda Warmer Modifiction to Giraffe and Panda Warmer- Infant…Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are… | Ohmeda Medical | 11/18/2016Terminated |
| Z-1507-2017 Class II | Giraffe Bedded Warmer, Panda Warmer Modification to Giraffe and Panda Warmers (Giraffe…Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are… | Ohmeda Medical | 11/18/2016Terminated |
| Z-1506-2017 Class II | Giraffe Bedded Warmer, Panda Warmer Giraffe and Panda Warmer- Infant radiant warmers…Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are… | Ohmeda Medical | 11/18/2016Terminated |
| Z-1504-2017 Class II | Giraffe OmniBed Ohmeda Medical Giraffe OmniBed- The OmniBed is a combination of an…Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are… | Ohmeda Medical | 11/18/2016Terminated |
| Z-1015-2017 Class II | Infant Warmer System (IWS)GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater… | GE Healthcare, LLC | 08/04/2016Terminated |
| Z-2295-2016 Class II | Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105…Risk associated with operating the device in skin temperature mode with temperature sensors attached but no… | Draeger Medical, Inc. | 06/22/2016Terminated |
| Z-0345-2016 Class II | HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON…DeRoyal manufactured four lots of HNICU-32, Hydro-Temp(R) Neonatal Temperature Skin Sensor incorrectly. The… | DeRoyal Industries Inc | 10/14/2015Terminated |
| Z-0210-2015 Class II | Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel…Breakage of the nut that secures the heater head in place, which can cause the heater head to become… | Fisher & Paykel Healthcare, Ltd. | 11/06/2014Terminated |
| Z-1551-2014 Class II | Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part…Medical device software may be defective and may cause user-set alarm limits to result in false positive or… | GE Healthcare | 04/02/2014Terminated |
| Z-1550-2014 Class II | Panda Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat…Medical device software may be defective and may cause user-set alarm limits to result in false positive or… | GE Healthcare | 04/02/2014Terminated |
| Z-1549-2014 Class II | Panda Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared…Medical device software may be defective and may cause user-set alarm limits to result in false positive or… | GE Healthcare | 04/02/2014Terminated |
| Z-1548-2014 Class II | Panda iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to…Medical device software may be defective and may cause user-set alarm limits to result in false positive or… | GE Healthcare | 04/02/2014Terminated |
| Z-1547-2014 Class II | Giraffe Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to…Medical device software may be defective and may cause user-set alarm limits to result in false positive or… | GE Healthcare | 04/02/2014Terminated |
| Z-0913-2014 Class II | Panda iRes Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part…Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to… | GE Healthcare | 12/12/2013Terminated |
| Z-0912-2014 Class II | Giraffe Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880…Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to… | GE Healthcare | 12/12/2013Terminated |
| Z-1693-2009 | Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA…Spark, flame and smoke: A mis-positioned crimp on heater element lead wire resulted in flame and smoke… | Draeger Medical Systems, Inc. | 07/29/2009Terminated |
| Z-1955-2009 | Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000…Hot particles fell into the infant bassinet beneath a Radiant Infant Warmer. The resulting fire injured an… | Draeger Medical Systems, Inc. | 07/17/2009Terminated |
| Z-2227-2008 | Panda iRes and Giraffe Infant Warmers, labeled in part*** GE Healthcare 8880 Gorman Road…Medical device software may be subject to signal interference of the Hands Free Alarm Silence feature that… | Datex Ohmeda, Inc. dba GE Healthcare | 05/20/2008Terminated |
| Z-0485-2007 | Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrated bed) fitted with…This firm has received Product Complaint Reports concerning bending of the pivot plate. The elevator base of… | Fisher & Paykel Healthcare Ltd | 10/09/2006Terminated |