Database updated: 19 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37706 |
| Brand Name: | Senographe Pristina VIA systems |
| Model: | Senographe Pristina VIA 3D+2D |
| Affected: | Certain clauses of IEC60601-2-45 Edition 3.1/3.2 standard |
| Software version: | |
| Recalling Organisation: | GE Healthcare Limited Level 7, Vero Centre 48 Shortland St Auckland 1010 |
| Contact Information: | 0800 659 465 |
| Manufacturer: | GE Medical Systems SCS |
| Issue: | The manufacturer 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 issue could result in a minor additional X-ray dose being delivered to the patient and obvious artifacts in the image (collimator blades). |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 13/10/2026 |
