Somatom Definition As And Flash (2019-07-18)

Recall Summary Siemens Healthineers is recalling SOMATOM Definition AS and Flash CT scanner models distributed across Canada due to a potential software issue that could affect image quality or patient safety. The FDA classified this as a Class I recall, the most serious category. The devices were distributed to medical facilities nationwide in Canada.

Reason
Medical devices
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2019-07-26
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/92e76e79-44c8-4129-a636-3990e5ee2d0d