Mammomat Revelation (2020-03-05)

MAMMOMAT Revelation Recall Summary Siemens Healthineers is recalling MAMMOMAT Revelation mammography systems distributed across Canada due to a potential software issue that could affect image quality or patient positioning during breast cancer screening exams. This Class I recall applies to all MAMMOMAT Revelation units in use. The affected devices are mammography machines used in medical facilities for diagnostic imaging.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2020-04-15

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/855ff2c8-cf35-46c6-9996-c5d3f81ada64