Cobas It Middleware (2019-07-26)

Recall Summary Cobas IT Middleware software used with certain medical devices has been recalled across Canada due to issues that could affect device performance or safety. The recall is classified as Class I, meaning there is a potential for serious harm or death. This recall applies to medical device users and healthcare facilities in Canada that have this middleware software.

Reason
Medical devices
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2019-08-16
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/529c91c4-26ae-4563-9530-98e7e988de92