| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01081-1 |
| Product Name/Description |
Resuscitation Systems with blender field upgrade installed in GE Giraffe and Panda Warmers (infant radiant warmer)
ARTG Number: 139290 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
23/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has recently become aware of a potential safety issue wherein the Oxygen and Air wall inlet fittings and/or labels on the back panel, were reversed during assembly. As a result, this may potentially have reversed Air/Oxygen mixer concentrations; for example, a setting of 100% Oxygen could have an output of 21% Oxygen, and vice versa. The settings of the blender knob will no longer be accurate. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
If the affected unit is in use with a patient, GE is asking customers to disconnect the wall supply gas and switch to tank supply. If the affected unit is not currently in use, GE is asking customers to take the unit out of service. A GE Field Engineer will be deployed to the affected site to complete the required repair. |
| Contact Information |
1300 722 229 - GE National Service and Support Centre |