Synapse Pacs Versions 5.x (2020-10-05)

Synapse PACS Versions 5.x Recall Summary Synapse PACS software versions 5.x (released October 5, 2020) is being recalled across Canada. The recall was issued because the software is classified as a medical device that does not meet regulatory requirements. This recall affects all users of Synapse PACS version 5.x in Canada.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2020-11-06

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/413af20d-3701-40f7-b3a9-59ce3690f07d