510(k) · Cleared
Recalled · Class I · 2026Ohmeda Medical Giraffe Omnibed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ohmeda Medical · FMZ Incubator, Neonatal
Cleared on May 9, 2002 as substantially equivalent to K993407 (Ohmeda Medical, 2000) and 2 other predicates after a 79-day review. Its family tree reaches back 1 generation to 1997. 3 of the 10 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it. It has been recalled 10 times, including 2 Class I recalls.
- Decided
- May 9, 2002
- Review
- 79 days
- Class
- Class II
- Product code
- FMZ
- Recalls
- 10 (2 Class I)
- Predicates
- 3
Its longest line of descent runs back 1 generation to K954204 (1997). 3 ancestors in all. 6 later devices descend from it, 2 citing it directly. 3 of the 10 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK954204 Drager Incubator 8000 ICDrager, Inc. · 1997
- This deviceK020543 Ohmeda Medical Giraffe OmnibedOhmeda Medical · 2002
- Descendant · cites it directly · 5 of its ownK071175 Ohmeda Medical Giraffe OmnibedGE Healthcare · 2007
- Descendant · cites it directly · 3 of its ownK152814 Giraffe OmniBed Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company · 2016 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK213553 Giraffe Incubator Carestation CS1Datex Ohmeda, Inc. · 2022 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK251663 Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc. · 2025
- Descendant · 4 generations on · 0 of its ownK260326 Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation…Datex-Ohmeda, Inc. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K071175Ohmeda Medical Giraffe OmnibedGE Healthcare · 2007 · cites it directly5descendants
- K152814Giraffe OmniBed Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company · 2016 · cites it directly3descendants
- K213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc. · 2022 · 2 generations on2descendants
- K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc. · 2025 · 3 generations on1descendant
- K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)Datex-Ohmeda, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954204 | Drager Incubator 8000 IC | Drager, Inc. | 1997 | — |
| 0 (this device) | K020543 | Ohmeda Medical Giraffe Omnibed | Ohmeda Medical | 2002 | — |
| +1 | K071175 | Ohmeda Medical Giraffe Omnibed | GE Healthcare | 2007 | — |
| +1 | K152814 | Giraffe OmniBed Carestation CS1 | Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company | 2016 | Class I |
| +2 | K213553 | Giraffe Incubator Carestation CS1 | Datex Ohmeda, Inc. | 2022 | Class I |
| +3 | K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | Datex-Ohmeda, Inc. | 2025 | — |
| +4 | K260326 | Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1) | Datex-Ohmeda, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 1 |
| 2022 | 1 | 1 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FMZ device
- #1 K251663 Giraffe OmniBed Carestation (CS1); Giraffe…score 14.4 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K993407 | Ohmeda Medical OmnibedSummary page 1…vice Information The Giraffe OmniBed is substantially equivalent to the following Class II devices: Device Last 510(k) Number Ohmeda Medical Giraffe OmniBed (original) K993407 Drager Incubator 8000 IC K954204 Isolette Infant Incubator Model C2HS K001242 Product Description The Ohmeda Medical Giraffe Om… | 2000 |
| * | K954204 | Drager Incubator 8000 ICSummary page 1…iBed is substantially equivalent to the following Class II devices: Device Last 510(k) Number Ohmeda Medical Giraffe OmniBed (original) K993407 Drager Incubator 8000 IC K954204 Isolette Infant Incubator Model C2HS K001242 Product Description The Ohmeda Medical Giraffe OmniBed is an infant bed which prov… | 1997 |
| * | K001242 | Isolette Infant Incubator, Model C2HSSummary page 1…wing Class II devices: Device Last 510(k) Number Ohmeda Medical Giraffe OmniBed (original) K993407 Drager Incubator 8000 IC K954204 Isolette Infant Incubator Model C2HS K001242 Product Description The Ohmeda Medical Giraffe OmniBed is an infant bed which provides thermal support for infants who are unab… | 2000 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 1, 2026 | Class II | Z-2475-2026 | Component design/selection | GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the… |
| May 1, 2026 | Class II | Z-2477-2026 | Component design/selection | GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the… |
| Sep 3, 2024 | Class I | Z-0047-2025 | Use error | GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification. This may lead to the doors… |
| May 19, 2023 | Class II | Z-2101-2023 | Nonconforming Material/Component | GE HealthCare has become aware of the potential that an incorrect type of secondary latch could have been installed on the northeast (NE) and/or northwest (NW) bedside panels for certain Giraffe OmniBed and Giraffe OmniBed Carestation… |
| Apr 28, 2020 | Class II | Z-2235-2020 | Device Design | Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen Module is installed. |
| Oct 11, 2019 | Class I | Z-0538-2020 | Device Design | Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall. |
| Nov 18, 2016 | Class II | Z-1504-2017 | Under Investigation by firm | Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fire, charring, smoke, or sparking where… |
| Apr 25, 2005 | Not classified | Z-1047-05 | Other | Neonatal incubators and beds may unintentionally move from a safe position following an interruption in the power supply. |
| Oct 17, 2003 | Not classified | Z-0288-04 | Other | Heater vent door on neonatal incubator may malfunction. |
| Jun 13, 2003 | Not classified | Z-1064-03 | Other | Firm's received complaints of medical device malfunction affecting instrument's calibration and alarm systems. |
The 5 latest of 10 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K152814Giraffe OmniBed Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company · 2016 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 13 Class I recalls
- K213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc. · 2022 · 2 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All FMZ devicesFMZ Incubator, Neonatal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMZ
60in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMZ
2in 2024
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · FMZ
250in 2025
MAUDE reports naming product code FMZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 81 | 0 | 14 |
| 2008 | 1 | — | 4 | 10 |
| 2009 | 0 | — | 0 | 8 |
| 2010 | 4 | 60 | 0 | 11 |
| 2011 | 1 | — | 5 | 10 |
| 2012 | 0 | — | 0 | 12 |
| 2013 | 0 | — | 1 (1) | 11 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 9 |
| 2016 | 1 | — | 1 | 12 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 2 | — | 3 | 18 |
| 2019 | 2 | — | 1 | 24 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 15 |
| 2022 | 1 | — | 0 | 27 |
| 2023 | 0 | — | 8 (8) | 19 |
| 2024 | 0 | — | 2 (2) | 118 |
| 2025 | 2 | — | 0 | 250 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user’s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperatures controlled environment and…
Read the full statement (138 words)
The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user’s demand. It cannot be operated in both modes at the same time.
Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperatures controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate’s transition from the uterus to the external environment. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020543 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020543: Ohmeda Medical Giraffe Omnibed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020543
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026