O-arm 1000 Imaging System (2018-09-06)

The O-Arm 1000 Imaging System is being recalled across Canada. The device was recalled due to a medical device issue, though the specific technical problem is not detailed in this notice. This recall affects all O-Arm 1000 Imaging Systems distributed in Canada.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2018-09-28

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/950b4a3e-a4d2-4ef4-903d-7969c04c75c8