| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01089-1 |
| Product Name/Description |
Brivo CT315/325, Brivo CT385, Optima CT520 and Optima CT540 (all configurations)
ARTG Number: 93337 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has recently become aware of a potential safety issue related to the Manual Film Composer feature on some CT products. While following a specific workflow, there is potential to create a film image with one patient's images and another patient’s name in the footer. There is also another issue when within Manual Film Composer, if a colour image is selected for printing, another patient’s black and white image appears in the preview screen and the colour image cannot be printed. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
As a temporary work around, GE is asking customers to always review the patient images and patient name on footer in the Manual Film Composer feature to ensure that they match . GE is providing temporary work around instructions on how to print the colour image from the Manual Film Composer. GE Healthcare will undertake a software update on each affected system as a permanent solution. |
| Contact Information |
1800 659 465 - National Call Centre |