Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:24664
Brand Name:X-Ray System, Mammographic, Stationary, Digital
Model:All Senographe Pristina systems that are equipped to receive a biopsy device.
Affected:
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 identified that if the Senographe Pristina gantry is rotated and the biopsy positioner is attached, the angulation angle may unexpectedly change during a motorized angulation motion, due to insufficient brake performance.
Recall action type:Correction
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:5/6/2019
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