Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:24896
Brand Name:Mammomat Fusion/Inspiration
Model:MAMMOMAT Revelation VC10 with Biopsy Option
Affected:
Software version:
Recalling Organisation:Siemens Healthcare (NZ) Ltd
Millennium Centre, Part Level 2, Building A
600 Great South Road
Ellerslie
AUCKLAND 1051
Contact Information:0800 310 300
Manufacturer:Siemens Healthcare GmbH
Issue:The manufacturer has become aware of an error that can occur when performing a biopsy using the InSpect function. The acquisition workstation can become unresponsive to normal user interaction. The issue can only occur in rare cases if all interactions happen: the workflow changes during biopsy by switching to the InSpect mode (the user double clicks the InSpect projection view icon) and, at the same time the user performs a right-mouse click at the acquisition workstation while the InSpect projection view is becoming active (changes color to white).
Recall action type:Correction
Recall action:Software to be upgraded
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:30/7/2019
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