Butterfly iQ+ Ultrasound System (2020-11-19)

Starting date:

November 19, 2020

Posting date:

July 7, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-75979

Last updated:
2021-07-07

• 
  Reason
• 
  Affected products

Affected Products 

Butterfly iQ+ Ultrasound System

Reason

On 2020-11-18, it was determined that Butterfly iQ+ devices were shipped to Canadian customers due to a clerical error. Although licensed to distribute in USA, the EU and elsewhere, Butterfly Network does not have a medical device license to distribute the iQ+ in Canada, only its predecessor, the Butterfly iQ.

Affected products