Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 21016 |
| Brand Name: | Siemens Mammomat Fusion/Inspiration |
| Model: | |
| Affected: | 10140000 with software version VB30 and with a Biopsy option |
| 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 potential errors that may occur while performing a biopsy. The system may freeze and the biopsy functionality may become not available in the following situations: a) Drop of the compression force, e.g. this may occur due to a patient sudden movement during the active targeting phase. b) Or use of the inversion tool while the scout image is active during the targeting phase |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 16/1/2017 |
