Product Wiki · Recalls · Health Canada — Medical Devices

Mammomat Inspiration System - Main Unit — recall 44409

Health Canada — Medical Devices · Canada · 2017-02-01 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
44409
Date of alert
2017-02-01
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/mammomat-inspiration-system-ma

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