Reflux Software V6.1 (2019-09-18)

Reflux Software V6.1 from September 18, 2019 has been recalled across Canada due to issues classified as a Class I medical device concern. This is the most serious type of recall, indicating a potential serious adverse health effect or death. The recall affects medical devices in the drugs category that use this software.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-12-06

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/820c91bc-9452-443f-92c8-04c61de62761