Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26007 |
| Brand Name: | Incubator, infant, stationary |
| Model: | Certain Giraffe Incubators and Giraffe OmniBeds - Oxygen sensor compatibility with Giraffe Systems |
| Affected: | |
| Software version: | |
| Recalling Organisation: | GE Healthcare Limited Level 7, Vero Centre 48 Shortland St Auckland 1010 |
| Contact Information: | 0800 659 465 |
| Manufacturer: | Datex-Ohmeda Inc |
| Issue: | The manufacturer has become aware that certain Giraffe Incubators and Giraffe OmniBeds manufactured before 2012 can 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 in your device. The Servo Oxygen Module automatically regulates oxygen that is provided internally by the device. Standard pulse oximetry monitoring will detect patient oxygen level changes and therefore this issue should only result in temporary hypoxia or hyperoxia. |
| Recall action type: | Correction |
| Recall action: | Product to be exchanged |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 7/5/2020 |
