Giraffe Panda Disposable Skin Temperature
Giraffe Panda Disposable Infant Skin Temperatur Probe
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) | K123309 |
| Record published | 2021-11-10 |
| Record revised | 2025-12-08 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Storage | Handling environment humidity 0 to 95 % RH; Storage environment temperature -25 to 60 °C; Handling environment temperature -25 to 60 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NA | 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
27 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 |
|---|---|---|---|---|---|---|---|
| Datex-Ohmeda, Inc. | 510(k) number | 2026-05-08 | Class I | Process control | 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 | 550 (367 US; 183 OUS) | |
| Datex-Ohmeda, Inc. | 510(k) number | 2026-05-08 | Class I | Process control | 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 | 550 (367 US; 183 OUS) | |
| 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 | 23430 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 | ||
| Wipro GE Healthcare Private Ltd. | 510(k) number | 2024-08-09 | Class II | Process control | 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. Howeve | 1 | |
| Wipro GE Healthcare Private Ltd. | 510(k) number | 2024-08-09 | Class II | Process control | 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. Howeve | 137 units | |
| Datex-Ohmeda, Inc. | 510(k) number | 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 | |
| Datex-Ohmeda, Inc. | 510(k) number | 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 | |
| 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 | 4,540 units | |
| 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. | 7814 units | 2024-08-15 |
| 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. | 3467 units | 2024-08-15 |
| GE Medical Systems, LLC | 510(k) number | 2019-07-26 | Class II | Nonconforming Material/Component | Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall. | 59 devices (50 US, 9 OUS) | |
| GE Medical Systems, LLC | 510(k) number | 2019-03-15 | Class I | Device Design | 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. | 9,094 devices | 2024-05-21 |
| GE Medical Systems, LLC | 510(k) number | 2019-03-15 | Class I | Device Design | 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. | 28,094 units | 2024-05-21 |
| 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 | 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 Healthcare GmbH | 510(k) number | 2014-04-02 | Class II | Software design | Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver. | 50 units | 2016-05-11 |
| GE Healthcare GmbH | 510(k) number | 2014-04-02 | Class II | Software design | Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver. | 723 units | 2016-05-11 |
| GE Healthcare GmbH | 510(k) number | 2014-04-02 | Class II | Software design | Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver. | 21 units | 2016-05-11 |
| GE Healthcare GmbH | 510(k) number | 2014-04-02 | Class II | Software design | Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver. | 15 units | 2016-05-11 |
| GE Healthcare GmbH | 510(k) number | 2013-12-12 | Class II | Process control | Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients. | 1970 units | 2015-06-01 |
| GE Healthcare GmbH | 510(k) number | 2013-12-12 | Class II | Process control | Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients. | 9232 units | 2015-06-01 |
Recalls
1 of these is 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 | |
| 2023-05-19 | 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 |
| 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.