Xp003/20/p Mammomat Revelation Amc Box: Grey Images (2020-04-08)

Siemens Healthineers Mammomat Revelation AMC Box Recall Siemens Healthineers is recalling the XP003/20/P Mammomat Revelation AMC Box mammography system across Canada because it may produce grey or unclear images that could affect diagnostic quality. This is a Class I recall, meaning there is a serious potential health risk. The device was distributed nationwide in Canada.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2020-05-08

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/72d7051f-5938-40b6-a5b4-fe325526a891