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Mammomat Inspiration System - Main Unit
- Starting date:
- January 12, 2017
- Posting date:
- February 1, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-62058
Reason
Potential software issues on Mammomat Inspiration with system version VB30 and biopsy functionality. The system may freeze and the biopsy cannot be continued in the following situations: the compression force drops, e.g. due to patient movement, during the active targeting phase, or, during the targeting phase the inversion tool is used while the scout image is active. As a result of the system freeze, the biopsy may have to be repeated.
Affected products
Mammomat Inspiration System - Main Unit
Lot or serial number
2046
4011
6537
6559
6639
Model or catalog number
101 40 000
10660834
Companies
- Manufacturer
-
Siemens Healthcare GMBH
HENKESTRASSE 127
ERLANGEN
91052
GERMANY