Shoebox Audiometry Pro (2018-11-06)

SHOEBOX Audiometry Pro Recall Summary The SHOEBOX Audiometry Pro device is being recalled in Canada because it is classified as a medical device that does not meet regulatory requirements. This recall affects all units of this audiometry product that were distributed across Canada. The device is used for hearing testing and assessment.

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/99798ff8-ad5f-4178-8f47-d8b0d054ef2f