GE Healthcare has identified a potential fault with the air-oxygen blender knob shaft on certain giraffe and panda warmers with integrated resuscitation systems and Giraffe stand-alone infant resuscitation systems. The shaft can loosen, causing the device to deliver an oxygen concentration that does not match the setting, which could result in hypoxia or hyperoxia for an infant.
Action Required
- Inspect all affected Giraffe/Panda resuscitation systems to identify whether they contain an affected blender (using Appendix 1 and the serial number list in Appendix 2 of the Field Safety Notice).
- If an affected blender is identified, remove the device from patient use immediately and contact GE Healthcare Service.
- If the device must be used before correction, complete the required pre-use checks, perform the multipoint oxygen concentration check, and verify oxygen concentration frequently using an independent oxygen analyser until the device is corrected as per Field Safety Notice.
Further information
Please refer to the manufacturer's Field Safety Notice for the full details, including affected product models, the list of affected blender serial numbers, identification instructions, and the customer acknowledgement form.
Questions
For queries regarding this recall, please contact the Manufacturer:
GE Healthcare UK – Patient Care Solutions Service Centre
- Phone: 0800 387 377
- Email: [email protected]
For internal queries, staff should also contact the Clinical Engineering / Medical Devices Team in line with local reporting procedures.
Priority
Critical – Immediate action required
Affected devices must be identified and removed from patient use immediately upon receipt of this alert. This is a manufacturer Field Safety Notice due to the potential for critical patient harm if an affected device is used.
