| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00023-1 |
| Product Name/Description |
Giraffe Incubator and Giraffe OmniBed with Servo Oxygen Control System
Manufactured between August 1 2012 and December 20 2012
Multiple serial numbers affected
ARTG Number: 139289
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
8/01/2013 |
| Responsible Entity |
|
| Reason/Issue |
When the giraffe OmniBed and Giraffe Incubator is powered "on" or there is a recovery from power failure, the oxygen set point or radiant heater set point (values that are entered by the clinician) may be overwritten due to a potential overwriting of stored information associated with the display printed circuit board. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
GE Healthcare is advising hospitals may continue to use the affect product, however, all set points must be confirmed when powering 'on' the Giraffe microenvironment or when recovering from a power failure event. A software update will be provided by GE Healthcare to correct the issue. |
| Contact Information |
1300 722 229 - GE National Service and Support Centre |