Somatom Definition As - Main Unit And Somatom Definition Edge System - Ct System (2019-09-05)

Recall Summary Siemens Healthineers is recalling Somatom Definition AS and Somatom Definition Edge CT scanner systems across Canada because the devices may not properly transmit patient data to hospital information systems, potentially resulting in incomplete or missing patient records. This recall affects medical facilities that use these CT imaging systems. The FDA has classified this as a Class I recall, indicating a serious issue.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-10-11

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/04a8658b-3017-4b22-bea9-c7991bb15cb6