| TGA Action ID |
RC-2026-RN-00808-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Senographe Pristina VIA Systems
GTIN: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026, 00198953109281, 10198953054311, 10195278901764 |
| ARTG Number |
111376 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
GE HealthCare has become aware of a nonconformance to certain clauses of IEC60601-2-45 Edition 3.1/3.2 standard in some Senographe Pristina VIA systems. Specifically, in cases of 3D+2D manual mode where the acquisition configuration of the anode track/filter combination is different, it can result in the following:
• the collimator blades might be visible in the image, or the collimator might be open more than expected, and
• an incorrect collimator filter might be used with respect to the anode track selected
This problem could result in a minor additional X-ray dose being delivered to the patient and obvious artifacts in the image (collimator blades).
There have been no injuries reported to GE HealthCare as a result of this problem. |
| Instructions for Customers/Users |
GE HealthCare will correct all affected products. A GE HealthCare representative will contact customers to arrange for the correction.
Pending correction by GE HealthCare, customers can continue to use the device as intended by following the instructions below:
- When using the 3D+2D manual mode, ensure you keep the same Anode Track / Filter combination for the 3D and the 2D acquisitions per the suggested manual acquisition techniques within the Operator Manual.
After the correction has been implemented, please be sure to destroy the installation media for affected software. |
| Action Commencement Date |
15/10/2026 |
| Responsible Entity |
|
| Contact Information |
1800 659 465 - GE HealthCare |