Butterfly Iq+ Ultrasound System (usb-c) Coo Taiwan

Recall Summary Butterfly iQ+ Ultrasound System devices manufactured in Taiwan with USB-C connections are being recalled across Canada because they are unauthorized medical devices that have not been properly approved for use in Canada. This is a Class I recall, which indicates a serious safety or effectiveness concern. The recall affects all Butterfly iQ+ Ultrasound System (USB-C) units with Taiwan as the country of origin that were distributed in Canada.

Product
Butterfly iQ+ Ultrasound System (USB-C) COO Taiwan
Reason
Unauthorised device
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2024-02-02
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/97ddc203-fc86-466c-b2b5-35161313bcca