| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01058-1 |
| Product Name/Description |
Revolution CT Scanners, software version 15MW03.12
ARTG Number: 156650 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/10/2015 |
| Responsible Entity |
|
| Reason/Issue |
A potential hazardous situation can occur during a routine head scan with possible artefacts that may emulate pathology between the brain tissue and bone in the head images. No injuries have been reported to date related to this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
To minimise the effects of beam hardening artefacts during routine head scans, GE Healthcare recommends that in addition to the information in the existing CT User Manual, the site also follow the additional recommendations identified in the customer letter. GE Healthcare will be delivering an addendum to the User Manual that reiterates these mitigations. Additional improvements to image quality are currently in development. This software will be distributed and installed on affected systems. This action has been closed-out on 29/08/2016. |
| Contact Information |
1800 659 465 - GE National Call Centre |