Mammomat Revelation (2020-05-11)

Recall Summary Siemens Healthineers is recalling Mammomat Revelation mammography systems distributed across Canada due to a potential software issue that could affect image quality and diagnostic accuracy. The recall applies to all Mammomat Revelation units in use. This is classified as a Class I recall, the most serious category for medical devices.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2020-06-05

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/7fdf2ec2-8c75-47f6-bd0d-e5a79e165981