| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01295-1 |
| 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 and Resuscitation System field upgrade kits with Blender (infant radiant warmers)
Multiple serial numbers affected
ARTG Number: 139290 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
4/12/2013 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has recently become aware of a potential safety issue wherein the Oxygen and Air wall or tank inlet fittings in the back panel, were reversed during assembly. As a result, this may potentially have reversed Air/Oxygen gas 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 in the affected units.
There is a risk of over delivery or under delivery of oxygen which may result in Hyperoxia or Hypoxia. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is advising users to perform a check of blender accuracy as per the Service Manual to verify O2 concentration set at 21% is within 16-26% and the concentration at 100% setting is within 95-105%. GE is providing a Pass/Fail form to be used for these checks.
- If the unit is not within these settings, discontinue use and send completed Pass/Fail form to GE in order to get the unit repaired.
- If the unit within these settings, continue using the device. |
| Contact Information |
1800 659 465 - GE Healthcare National Call Centre |