S5i Imaging System (2018-11-08)

Recall Summary The s5i Imaging System has been recalled across Canada due to safety concerns with the medical device. This is a Class I recall, indicating a serious issue that could result in significant harm. The recall affects all units of this imaging system distributed in Canada.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2018-11-28

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/25979e37-d97d-429d-8b84-f86d7ef20eae