Patient Data Module (2021-06-14)

Recall Summary A Patient Data Module software component used in medical devices is being recalled across Canada due to a safety issue with the device classification. This recall affects medical devices that contain this software component.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2021-06-23

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/9184f112-8683-44c1-89b4-1aee70253cbc