Giraffe
Giraffe Warmer
3manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| 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 | FMT |
| Device type | Warmer, Infant Radiant |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5130 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K070377 |
| Record published | 2016-06-24 |
| Record revised | 2026-01-07 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 0 to 85 % RH; Storage environment temperature -25 to 38 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Warmer | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 37 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 9 |
| AirLife™ | AirLife Finland Oy | 8 |
| Tarry Probes | Tarry Medical Products, Inc. | 5 |
| Argyle | Cardinal Health | 5 |
| Panda | Datex-Ohmeda, Inc. | 4 |
| AccuTemp Probe | Kentec Medical, LLC | 3 |
| Ameritus | Kentec Medical, LLC | 3 |
| AirLife | Carefusion Finland 320 Oy | 3 |
| F&P Neopuff | Fisher & Paykel Healthcare, Ltd. | 2 |
| Sunflower Warmer, Stand AC120V | Atom Medical Corporation | 2 |
| Heating Element 540W-104V | RPI | 2 |
Showing 12 of 39. All products under Warmer, Infant Radiant
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213551 | 2022-03-02 |
Recalls Naming This Product
19 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) | |
| 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 | |
| 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 |
| Ohmeda Medical | 510(k) number | 2016-11-18 | Class II | 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 the | 5,993 (5,080 US; 913 OUS) | 2018-07-13 |
| Ohmeda Medical | 510(k) number | 2016-11-18 | Class II | 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 the | 5,993 (5,080 US; 913 OUS) | 2018-07-13 |
| 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 |
| Datex Ohmeda, Inc. dba GE Healthcare | 510(k) number | 2008-05-20 | Not classified | Software design | Medical device software may be subject to signal interference of the Hands Free Alarm Silence feature that could impact patient safety. | 639 devices | 2012-05-11 |
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.