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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00335-1
Product Name/Description	Butterfly iQ/ iQ+/ iQ3 diagnostic ultrasound imaging system Software version: 2.33.0 ARTG 318962 (General ultrasound imaging system, battery-powered)
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	30/04/2024
Responsible Entity	Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Reason/Issue	A software bug has been identified in version 2.33.0 where the application may crash on certain models of iOS devices (iPad and iPhone) when performing either a user-initiated, or mandatory diagnostic health check for your Butterfly iQ+ ultrasound probe. The problem is likely due to insufficient mobile device memory space on certain iOS models. iOS mobile devices impacted by this software bug include: iPad (9th Generation), iPad (8th Generation), iPad (7th Generation), iPad Air (3rd Generation), iPad mini (5th Generation), iPad (6th Generation), iPad (5th Generation), iPad Pro 9.7", iPhone SE (2nd Generation), iPhone XR, iPhone X, iPhone 8 Plus, iPhone 8
Recall Action	Product Defect Correction
Recall Action Instructions	Customers are to upgrade their Butterfly iQ app through the Apply App Store to software version 2.33.1 and re-execute the diagnostic health check. This action has been finalised on 30/7/2024.
Contact Information	02 9006 1662 - Emergo Australia