| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-01021-1 |
| Product Name/Description |
MEDRAD Centargo CT Injection System
Operating systems: v1.6 or v1.9 AND connected to VirtualCARE Remote Support
ARTG 297400
(Imaxeon Pty Ltd - CT contrast medium injection system, line-powered, mobile) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/11/2024 |
| Responsible Entity |
|
| Reason/Issue |
In August 2024, Microsoft disclosed a cybersecurity vulnerability impacting systems with IPv6 enabled. This vulnerability would allow an unauthenticated attacker, in a worst-case scenario exploit, to obtain full system access. Only the Centargo Injector System is vulnerable.
This recall action was not notified to the TGA prior to being undertaken |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Bayer will deploy a software patch for all Centargo Injection Systems operating on v1.6 or v1.9 AND connected to VirtualCARE Remote Support. Remote patch delivery should result in minimal workflow disruption; however, the patch may not fully apply until the system is rebooted.
If your Centargo device is NOT connected to VirtualCARE Remote Support and you wish to receive the patch, please contact the Bayer support team at 1800 633 7237, x1, to request a service visit or help to get your device connected. For customers under a service agreement, the patch will be installed on your next service visit.
If your Centargo device is operating on a prior software version than v1.6 or v1.9, contact the Bayer support team to receive the latest released version. |
| Contact Information |
1800 633 7237 - Bayer Support Team |