-spot, S-spot, And Tomospot (2018-06-13)

Recall Summary 0-SPOT, S-SPOT, and TomoSPOT medical devices are being recalled across Canada because they do not meet required quality and safety standards for medical devices. These devices were distributed nationwide in Canada. The recall is classified as Class I, which is the most serious type.

Reason
Medical devices
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2018-06-29
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/2c8b62af-f341-475d-b074-ff4d3544f1fd