Giraffe
Giraffe Shuttle
2manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code
7recalls on this code
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol (Changzhou) Connector Systems Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Datex-Ohmeda, Inc., United States |
|---|---|
| FDA product code | FMZ |
| Device type | Incubator, Neonatal |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5400 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K101778 |
| Record published | 2016-06-24 |
| Record revised | 2025-03-25 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -25 to 45 °C; Storage environment humidity 5 to 85 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Shuttle | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tarry Probes | Tarry Medical Products, Inc. | 7 |
| Midas Rex MR8 | Medtronic Powered Surgical Solutions | 6 |
| Airlife | AirLife Finland Oy | 6 |
| AirLife | Carefusion Finland 320 Oy | 5 |
| Multi-Link™ | AirLife Finland Oy | 3 |
| Access Medical Probes | Tarry Medical Products, Inc. | 3 |
| Advanced Neonatal Incubator | Advanced Instrumentations, Inc. | 2 |
| Babyleo TN500 | Drägerwerk AG & Co. KGaA | 2 |
| Isolette® 8000 plus | Draeger Medical Systems, Inc. | 2 |
| Isolette 8000 Infant Incubator | Draeger Medical Systems, Inc. | 1 |
| Skin Temp Probe, 5mm O.D.(Y) | Atom Medical Corporation | 1 |
| Oxygen Sensor For Dual Incu i, Incu i, V-2200/2100G(2 pcs/set) | Atom Medical Corporation | 1 |
Showing 12 of 41. All products under Incubator, Neonatal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260326 | 2026-07-28 |
| K251663 | 2025-10-22 |
| K213553 | 2022-03-02 |
| K072512 | 2007-10-03 |
Recalls Naming This Product
13 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| GE Medical Systems, LLC | 510(k) number | 2026-05-01 | Class II | 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 soffit | 19587 units | |
| GE Medical Systems, LLC | 510(k) number | 2026-05-01 | Class II | 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 soffit | 265 units | |
| Datex-Ohmeda, Inc. | 510(k) number | 2024-09-03 | Class I | 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 b | ||
| Datex-Ohmeda, Inc. | 510(k) number | 2023-05-19 | Class II | 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 devic | 3,053 units | |
| GE Medical Systems, LLC | 510(k) number | 2020-04-28 | Class II | 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. | 5,883 units total | 2024-09-23 |
| GE Medical Systems, LLC | 510(k) number | 2020-04-28 | Class II | 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. | 5,883 units total | 2024-09-23 |
| GE Medical Systems, LLC | 510(k) number | 2020-04-02 | Class II | Device Design | During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor. | 204 units. | 2024-05-06 |
| GE Medical Systems, LLC | 510(k) number | 2019-10-11 | Class I | 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. | 23,693 units | 2024-08-15 |
| GE Medical Systems, LLC | 510(k) number | 2018-09-25 | Class II | Process design | Potential electric leakage affecting the user. | 1,724 devices total | 2020-07-13 |
| GE Medical Systems, LLC | 510(k) number | 2018-09-25 | Class II | Process design | Potential electric leakage affecting the user. | 1,724 devices total | 2020-07-13 |
| GE Medical Systems, LLC | 510(k) number | 2018-09-25 | Class II | Process design | Potential electric leakage affecting the user. | 1,724 devices total | 2020-07-13 |
| GE Medical Systems, LLC | 510(k) number | 2018-09-25 | Class II | Process design | Potential electric leakage affecting the user. | 1,724 devices total | 2020-07-13 |
| GE Medical Systems, LLC | 510(k) number | 2013-01-08 | Class I | Process control | Neonatal beds and incubator display boards may randomly overwrite stored information and radiant heater and oxygen set points upon power up or recovery from a power failure. | 679 units | 2013-07-10 |
Recalls
3 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-09-03 | Class I | 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 b | |
| 2023-06-06 | Class I | Component design/selection | Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were noti | 224 units |
| 2023-06-06 | Class I | Component design/selection | Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were noti | 769 units |
| 2023-05-19 | Class II | 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 devic | 4,540 units |
| 2023-05-19 | Class II | 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 devic | 18 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.