| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01334-1 |
| Product Name/Description |
Giraffe Stand Alone Resuscitation Systems with Blender, Giraffe Warmer Integrated Resuscitation systems with Blender, Panda Warmer Integrated Resuscitation systems with Blender, Panda Freestanding Warmer Integrated Resuscitation Systems with Blender, Resuscitation System field upgrade kits with Blender
ARTG Number: 139290 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
18/12/2013 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has recently become aware of a potential safety issue associated with the loosening of the blender knob shaft on all Resuscitation units. A loose blender knob shaft may potentially affect the accuracy of the blended output of Air/oxygen gas mixture from the unit which could result in hypoxia or hyperoxia. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is advising users to perform a blender accuracy check as outlined in the service manual to verify the O2 concentration set at 21% and 100% settings are within the recommended range. If the blender accuracy test results do not meet specification, remove from patient use and contact GE Healthcare. If the blender accuracy results pass, the system is suitable for continued use, however GE is recommending that when delivering oxygen a pulse oximeter is used to monitor the patient.
GE Healthcare will be correcting all affected systems as a permanent fix. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |