Public recall detail

Butterfly iQ+ Ultrasound System (USB-C) COO Taiwan

2024-02-02

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Recall Safety notice
Quick summary

Quick summary: Butterfly iQ+ Ultrasound System (USB-C) COO Taiwan. Date: 2024-02-02.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Butterfly iQ+ Ultrasound System (USB-C) COO Taiwan. Date: 2024-02-02.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandButterfly Network Inc.
ProductButterfly iQ+ Ultrasound System (USB-C) COO Taiwan
IssueMedical devices - Unauthorised device
Recall classType II
IdentificationRA-75002

Affected products

ProductButterfly iQ+ Ultrasound System (USB-C) COO Taiwan
LotMore than 10 numbers, contact manufacturer.
Model900-20036-04
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionButterfly iQ+ Ultrasound System (USB-C) COO Taiwan

Issue

It was internally discovered that the additional product code 900-20036-04 was previously shipped in error to Canadian customers. Butterfly Network Inc.'s Health Canada medical device license no. 106128 for the Butterfly iQ+ Ultrasound System (USB-C) does not currently include this additional product code for distribution. Recall Start Date: January 22, 2024

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public
CategoryHealth products - Medical devices - General hospital and personal use
CompaniesButterfly Network Inc. 1600 District Ave, Burlington, Massachusetts, United States, 01803
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75002
Background{}
CompaniesButterfly Network Inc. 1600 District Ave, Burlington, Massachusetts, United States, 01803
AudiencesGeneral public
Source updated2024-02-02

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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