Kay Pentax Stroboscopy System (2020-09-11)

Recall Summary The Kay Pentax Stroboscopy System is being recalled across Canada due to a defect classified as a Class I medical device issue. This system is used for visual examination of voice box movement during speech and swallowing. The recall affects all units distributed in Canada.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2020-09-25

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/61fa0e62-1180-4fd1-abc3-11873572438b