Somatom Definition Edge

SOMATOM Definition Edge Recall Summary The SOMATOM Definition Edge CT scanner is being recalled in Canada due to a software defect. This recall affects all units of this medical imaging device that have been distributed across Canada. The defect is classified as a Class I recall, indicating a serious issue with the device's software.

Product
SOMATOM Definition Edge
Reason
Software defect
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2021-11-19
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/f99b96c4-f5c6-4a37-9e9d-d05430a50666