Incubator, Neonatal
FDA product code FMZ · Class II (moderate risk) · 21 CFR 880.5400 · General Hospital
86510(k) clearances
0PMA approvals
41recalls
Manufacturers
- Ohmeda Medical 15
- Air-Shields, Inc. 7
- Air-Shields Vickers, Inc. 6
- Atom Medical Corporation 5
- Vickers America Medical Corp. 4
- Datex-Ohmeda, Inc. 4
- Hill-Rom Air-Shields 2
- Medix I.C.S.A. 2
- Dragerwerk AG 2
- K-1 Medical Products, Inc. 2
- Preemicare Corp. 2
- Hollister, Inc. 2
- Narco Scientific 2
- Ohio Medical Products 2
- Adel Medical , Ltd. 1
- Egnell, Inc. 1
- Drägerwerk AG & Co. KGaA 1
- Mediprema 1
- First Touch Disposables, Inc. 1
- Narco Air-Shields 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260326 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)FMZ · Traditional | Datex-Ohmeda, Inc. | 07/28/2026SE |
| K251619 | Babyleo TN500FMZ · Traditional | Drägerwerk AG & Co. KGaA | 02/13/2026SE |
| K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)FMZ · Traditional | Datex-Ohmeda, Inc. | 10/22/2025SE |
| K243437 | mOm Essential Incubator (ME1)FMZ · Traditional | Mom Incubators Limited | 08/14/2025SE |
| K213553 | Giraffe Incubator Carestation CS1FMZ · Traditional | Datex Ohmeda, Inc. | 03/02/2022SE |
| K190494 | Infant IncubatorFMZ · Traditional | Ningbo David Medical Device Co., Ltd. | 11/25/2019SE |
| K182859 | Babyleo TN500FMZ · Special | Dragerwerk AG & CO Kgaa | 02/22/2019SE |
| K182977 | Isolette 8000 PlusFMZ · Special | Draeger Medical Systems, Inc. | 11/21/2018SE |
| K172154 | Isolette 8000 plusFMZ · Traditional | Draeger Medical Sytems, Inc. | 04/19/2018SE |
| K162821 | Babyleo TN500FMZ · Traditional | Draegerwerk AG & CO Kgaa | 06/23/2017SE |
| K152814 | Giraffe OmniBed Carestation CS1FMZ · Special | Ohmeda Medical, A Division of Datex-Ohmeda,Inc.… | 03/17/2016SE |
| K152809 | Giraffe Incubator Carestation CS1FMZ · Special | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 12/31/2015SE |
| K132543 | Infant IncubatorFMZ · Traditional | Bistos Co., Ltd. | 07/03/2014SE |
| K102226 | Dual Incu IFMZ · Traditional | Atom Medical Corporation | 01/04/2011SE |
| K102279 | Incu IFMZ · Traditional | Atom Medical Corporation | 12/29/2010SE |
| K102710 | Neo-Servo IFMZ · Traditional | Atom Medical Corporation | 12/22/2010SE |
| K101788 | Giraffe OmnibedFMZ · Special | Ohmeda Medical | 07/21/2010SE |
| K101778 | Giraffe IncubatorFMZ · Special | Ohmeda Medical | 07/21/2010SE |
| K071977 | Tarry Medical Temperature ProbesFMZ · Traditional | Tarry Medical Products, Inc. | 05/23/2008SE |
| K072512 | Modification to: Ohmeda Medical Giraffe Incubator (Giraffe and Panda Uninterruptible…FMZ · Special | Datex-Ohmeda, Inc. | 10/03/2007SE |
| K070291 | Medix Natal Care Intensive Care Incubator, Models-Natal Care St-Mx/Lx/BxFMZ · Traditional | Medix I.C.S.A. | 09/21/2007SE |
| K071175 | Ohmeda Medical Giraffe OmnibedFMZ · Special | GE Healthcare | 07/17/2007SE |
| K061856 | V-2200 Infant IncubatorFMZ · Traditional | Atom Medical, Inc. | 09/28/2006SE |
| K053399 | Versalet 7700 Care CenterFMZ · Traditional | Draeger Medical Infant Care, Inc. | 08/04/2006SE |
| K061280 | V-2200 Infant IncubatorFMZ · Traditional | Neoforce Group, Inc. | 06/27/2006SE |
| K040910 | Infant Incubator, Model CHS-I1000FMZ · Traditional | Choong Wae Medical Corp. | 04/21/2004SE |
| K040068 | Biliblanket Plus High Output Phototherapy SystemFMZ · Traditional | Ohmeda Medical | 04/16/2004SE |
| K031387 | Isolette Infant Incubator, Model C2000EFMZ · Traditional | Hill-Rom Manufacturing, Inc. | 08/01/2003SE |
| K021809 | V-2100G Advanced Infant IncubatorFMZ · Abbreviated | Atom Medical Corp | 07/18/2002SE |
| K020547 | Ohmeda Medical Giraffe IncubatorFMZ · Traditional | Ohmeda Medical | 05/09/2002SE |
| K020543 | Ohmeda Medical Giraffe OmnibedFMZ · Traditional | Ohmeda Medical | 05/09/2002SE |
| K010222 | Ohmeda Medical Giraffe IncubatorFMZ · Traditional | Ohmeda Medical | 03/21/2001SE |
| K003067 | CaleoFMZ · Abbreviated | Drager Medizintechnik GmbH | 12/13/2000SE |
| K001242 | Isolette Infant Incubator, Model C2HSFMZ · Traditional | Hill-Rom Air-Shields | 07/13/2000SE |
| K993051 | Versalet 7700 Care Center, Model # 7700FMZ · Traditional | Hill-Rom Air-Shields | 02/03/2000SE |
| K993407 | Ohmeda Medical OmnibedFMZ · Traditional | Ohmeda Medical | 01/05/2000SE |
| K993712 | Biliblanket Plus High Output Phototherapy SystemFMZ · Special | Ohmeda Medical | 11/09/1999SE |
| K980886 | Babytherm 8000 LDRFMZ · Traditional | Draeger Medical, Inc. | 05/29/1998SE |
| K974349 | Ohmeda-Ohio Care Plus IncubatorFMZ · Traditional | Ohmeda Medical | 02/12/1998SE |
| K954204 | Drager Incubator 8000 IcFMZ · Traditional | Drager, Inc. | 04/25/1997SE |
| K962806 | Ohmeda-Ohio Cae Plus IncubatorFMZ · Traditional | Ohmeda Medical | 09/20/1996SE |
| K960980 | Isolette Infant IncubatorFMZ · Traditional | Air-Shields, Inc. | 07/30/1996SE |
| K943360 | Ohio Care Plus IncubatorFMZ · Traditional | Ohmeda Medical | 09/29/1994SE |
| K940975 | C450/C400 Infant IncubatorsFMZ · Traditional | Air-Shields, Inc. | 06/23/1994SE |
| K924324 | K-1 Infant Transport System W/ Integral Air CompreFMZ · Traditional | K-1 Medical Products, Inc. | 11/12/1993SE |
| K922618 | BowronFMZ · Traditional | G.L. Bowron & Co. , Ltd. | 08/19/1993SE |
| K920049 | Medix PC-305 Neonatal IncubatorFMZ · Traditional | Medix I.C.S.A. | 05/21/1993SE |
| K924297 | Dewette 2 Isolette Incubator HumidifierFMZ · Traditional | Air-Shields Vickers, Inc. | 03/18/1993SE |
| K924170 | Isolette Incubator Humidity MeterFMZ · Traditional | Air-Shields, Inc. | 02/05/1993SE |
| K912000 | Type Interface 9271/1 Incubator/WarmerFMZ · Traditional | S & W Medico Teknik | 09/21/1992SE |
| K915752 | First Touch/Viledon Non-Woven FilterFMZ · Traditional | First Touch Disposables, Inc. | 09/17/1992SE |
| K914864 | Models C500/C550 Isolete(R) Infant IncubatorFMZ · Traditional | Air-Shields, Inc. | 03/13/1992SE |
| K914487 | Ohio Care Plus IncubatorFMZ · Traditional | Ohmeda Medical | 12/18/1991SE |
| K914134 | Incubator 8000 SCFMZ · Traditional | National Draeger, Inc. | 11/22/1991SE |
| K913394 | Incubator 8000 IcFMZ · Traditional | Dragerwerk AG | 11/22/1991SE |
| K913291 | Model C386 Isolette(R) Infant IncubatorFMZ · Traditional | Air-Shields, Inc. | 11/13/1991SE |
| K912909 | Solair (TM) Infant Incubator Transparent Hood WarmFMZ · Traditional | Air-Shields Vickers, Inc. | 11/05/1991SE |
| K912910 | C100 Infant Incubator Shelf/Mount Rail SystemFMZ · Traditional | Air-Shields Vickers, Inc. | 10/30/1991SE |
| K913154 | Ohmeda - Ohio Car Plus Incubator, ModificationFMZ · Traditional | Ohmeda Medical | 09/13/1991SE |
| K901157 | MP4, MP4SI, IT4 IncubatorsFMZ · Traditional | Mediprema | 03/27/1991SE |
| K903378 | Model C286 Isolette Infant IncubatorFMZ · Traditional | Air-Shields Vickers, Inc. | 10/15/1990SE |
| K900752 | Incubator 8000FMZ · Traditional | Dragerwerk AG | 08/02/1990SE |
| K901585 | Ohmeda - Ohio(R) Care Plus IncubatorFMZ · Traditional | Ohmeda Medical | 06/22/1990SE |
| K900735 | Model 130 Automatic Height Adjust (Aha) IncubatorFMZ · Traditional | Preemicare Corp. | 05/02/1990SE |
| K895782 | Neonatal Incubator (Accessory)FMZ · Traditional | Air-Shields Vickers, Inc. | 12/07/1989SE |
| K895550 | K-1 Infant Transport SystemFMZ · Traditional | K-1 Medical Products, Inc. | 12/07/1989SE |
| K890476 | Adel - Model 986 Infant WarmerFMZ · Traditional | Adel Medical , Ltd. | 06/16/1989SE |
| K881476 | Preemicare Model D1-X1, Series 3000FMZ · Traditional | Preemicare Corp. | 12/08/1988SE |
| K884086 | C100 QT Variable Height Adjustment IncubatorFMZ · Traditional | Air-Shields Vickers, Inc. | 11/14/1988SE |
| K870223 | Ameda Amelette(R) Neonatal IncubatorFMZ · Traditional | Hollister, Inc. | 06/10/1987SE |
| K870222 | Ameda Amecare(R) Neonatal IncubatorFMZ · Traditional | Hollister, Inc. | 06/10/1987SE |
| K871399 | Ohio(R) Care Plus IncubatorFMZ · Traditional | Ohmeda Medical | 06/05/1987SE |
| K840526 | AmethermFMZ · Traditional | Egnell, Inc. | 04/30/1984SE |
| K832418 | Ohio Temperature SimulatorFMZ · Traditional | Airco/Ohio Medical Products | 09/12/1983SE |
| K822656 | C-200 Infant IncubatorFMZ · Traditional | Narco Scientific | 10/18/1982SE |
| K821896 | C-300 Infant IncubatorFMZ · Traditional | Narco Scientific | 07/28/1982SE |
| K813239 | Oxygenaire Nuring IncubatorFMZ · Traditional | Vickers America Medical Corp. | 01/28/1982SE |
| K813238 | Neocare Baby-Controlled IncubatorFMZ · Traditional | Vickers America Medical Corp. | 01/22/1982SE |
| K810792 | Neocare Temperature MonitorFMZ · Traditional | Vickers America Medical Corp. | 04/29/1981SE |
| K810067 | 140 Neocare Air Controlled IncubatorFMZ · Traditional | Vickers America Medical Corp. | 03/11/1981SE |
| K802640 | Ohio GC IncubatorFMZ · Traditional | Ohio Medical Products | 11/12/1980SE |
| K802639 | Ohio Ic IncubatorFMZ · Traditional | Ohio Medical Products | 11/12/1980SE |
| K802126 | Isolette Incubator C-100FMZ · Traditional | Narco Air-Shields | 09/26/1980SE |
| K801461 | Therma-ShieldFMZ · Traditional | Olympic Medical Corp. | 07/28/1980SE |
| K781876 | Isolette IncubatorFMZ · Traditional | Air-Shields, Inc. | 12/07/1978SE |
| K780472 | Infant IncubatorFMZ · Traditional | Air-Shields, Inc. | 04/19/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2477-2026 Class II | Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and…GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel… | GE Medical Systems, LLC | 05/01/2026Open, Classified |
| Z-2476-2026 Class II | Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an…GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel… | GE Medical Systems, LLC | 05/01/2026Open, Classified |
| Z-2475-2026 Class II | Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All ModelsGE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel… | GE Medical Systems, LLC | 05/01/2026Open, Classified |
| Z-0048-2025 Class I | GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal…GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the… | Datex--Ohmeda, Inc. | 09/03/2024Open, Classified |
| Z-0047-2025 Class I | GE Heathcare Giraffe OmniBed; neo natal incubatorGE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the… | Datex--Ohmeda, Inc. | 09/03/2024Open, Classified |
| Z-0962-2024 Class I | GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767…GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and… | Wipro GE Healthcare Private Ltd. | 12/26/2023Open, Classified |
| Z-0961-2024 Class I | GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659…GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and… | Wipro GE Healthcare Private Ltd. | 12/26/2023Open, Classified |
| Z-0960-2024 Class I | GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800…GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and… | Wipro GE Healthcare Private Ltd. | 12/26/2023Open, Classified |
| Z-0959-2024 Class I | GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers:…GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and… | Wipro GE Healthcare Private Ltd. | 12/26/2023Open, Classified |
| Z-0958-2024 Class I | GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP…GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and… | Wipro GE Healthcare Private Ltd. | 12/26/2023Open, Classified |
| Z-0957-2024 Class I | GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus…GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and… | Wipro GE Healthcare Private Ltd. | 12/26/2023Open, Classified |
| Z-0141-2025 Class I | GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1)…Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from… | Datex--Ohmeda, Inc. | 06/06/2023Completed |
| Z-0140-2025 Class I | GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant…Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from… | Datex--Ohmeda, Inc. | 06/06/2023Completed |
| Z-2102-2023 Class II | Beside panel FRU (Field Replacement Units) KitsGE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been… | Datex--Ohmeda, Inc. | 05/19/2023Open, Classified |
| Z-2101-2023 Class II | Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901…GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been… | Datex--Ohmeda, Inc. | 05/19/2023Open, Classified |
| Z-2100-2023 Class II | Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b.…GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been… | Datex--Ohmeda, Inc. | 05/19/2023Open, Classified |
| Z-2307-2021 Class II | Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers…Units are displaying output readings that differ from the measurements taken using a Gas Analyzer. When the… | CooperSurgical, Inc. | 06/30/2021Terminated |
| Z-2236-2020 Class II | Giraffe Incubator with installed Servo Oxygen module. Infant incubator.Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen… | GE Healthcare, LLC | 04/28/2020Terminated |
| Z-2235-2020 Class II | Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen… | GE Healthcare, LLC | 04/28/2020Terminated |
| Z-2111-2020 Class II | Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN:…During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a… | GE Healthcare, LLC | 04/02/2020Terminated |
| Z-0281-2020 Class II | Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an…Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy… | GE Healthcare, LLC | 07/26/2019Open, Classified |
| Z-0041-2020 Class II | Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and…GE Healthcare has become aware of a potential safety issue that can occur if the canopy seals are not… | Ohmeda Medical | 10/05/2018Terminated |
| Z-0480-2019 Class II | Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following…Potential electric leakage affecting the user. | GE Healthcare, LLC | 09/25/2018Terminated |
| Z-0479-2019 Class II | Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product…Potential electric leakage affecting the user. | GE Healthcare, LLC | 09/25/2018Terminated |
| Z-1510-2017 Class II | CarePlus Incubator Ohmeda-Ohio CarePlus Incubator- Incubators provide a controlled…Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are… | Ohmeda Medical | 11/18/2016Terminated |
| Z-1509-2017 Class II | Giraffe OmniBed Ohmeda Medical Omnibed- The OmniBed is a combination of an infant…Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are… | Ohmeda Medical | 11/18/2016Terminated |
| Z-1505-2017 Class II | Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant…Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are… | Ohmeda Medical | 11/18/2016Terminated |
| Z-1502-2017 Class II | Giraffe Incubator The Giraffe Incubator is an infant incubator. Incubators provide heat…Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are… | Ohmeda Medical | 11/18/2016Terminated |
| Z-0056-2017 Class II | The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers:…NatalCare LX incubators may have a defective base where the weld holding the wheel bushing to the tube is… | Natus Medical Incorporated | 08/25/2016Terminated |
| Z-1363-2016 Class II | Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.NatalCare LX Incubators were manufactured using a defective oval port hinge assembly with the result that… | Natus Medical Incorporated | 01/08/2016Terminated |
| Z-1051-2013 Class I | Giraffe OmniBed and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part:…Neonatal beds and incubator display boards may randomly overwrite stored information and radiant heater and… | GE Healthcare, LLC | 01/08/2013Terminated |
| Z-1945-2012 Class II | Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo…There is a potential for the device's canopy to move unintentionally when using the incubator mode or… | Atom Medical Corporation | 05/01/2012Terminated |
| Z-0340-2012 | Infa Warmer i (Atom Infant Warmer Model 103) Atom Medical Corporation 3-18-15 Hongo…The caster with lock on the radiant-warming open type incubator may become loose or break. | Atom Medical Corporation | 08/23/2011Terminated |
| Z-0339-2012 | Rabee Incu i (Atom Infant Incubator Model 102) Atom Medical Corporation 3-18-15 Hongo…The caster with lock on the incubator may become loose or break. | Atom Medical Corporation | 08/23/2011Terminated |
| Z-0338-2012 | Incu i (Atom Infant Incubator Model 101) Atom Medical Corporation 3-18-15 Hongo…The caster with lock on the incubator may become loose or break. | Atom Medical Corporation | 08/23/2011Terminated |
| Z-0337-2012 | Dual Incu i (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo…The caster with lock on the incubator or infant warmer may become loose or break. | Atom Medical Corporation | 08/23/2011Terminated |
| Z-2414-2011 | Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i…Several models of the Intra-Aortic Balloon Pumps are being recalled due to a potential problem with the… | Maquet Datascope Corp - Cardiac Assist… | 03/16/2011Terminated |
| Z-0305-2009 | Giraffe OmniBed, labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723…Manufacturer of neonatal incubators changed the device labeling to account for new use and care instructions. | Datex Ohmeda, Inc. dba GE Healthcare | 06/20/2008Terminated |
| Z-1053-2008 | Draeger Globe Trotter IC, Catalog Number: MU20509, Draeger Medical, Inc., Telford, PA…Heating failure- The power board which controls the incubator heater may not regulate the temperature… | Draeger Medical, Inc. | 01/31/2008Terminated |
| Z-1052-2008 | Draeger GT500. GlobeTrotter Transport System. Catalog Number: MU20508, Draeger Medical…Heating failure- The power board which controls the incubator heater may not regulate the temperature… | Draeger Medical, Inc. | 01/31/2008Terminated |
| Z-1051-2008 | Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger Medical…Heating failure- The power board which controls the incubator heater may not regulate the temperature… | Draeger Medical, Inc. | 01/31/2008Terminated |