Iris X80, X90, And Pxl Intra-oral Cameras

Recall Summary Iris X80, X90, and PXL Intra-Oral Cameras are being recalled in Canada because they are unauthorized devices that have not received required regulatory approval. This recall applies to all units of these three camera models distributed across Canada.

Product
Iris X80, X90, and PXL Intra-Oral Cameras
Reason
Unauthorised device
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2024-12-30
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/2d43e764-83f1-4637-8680-8ef3bbe65b3e