Butterfly iQ+ for diagnostic ultrasound imaging

Regulatory information

Butterfly iQ+ is a CE-marked class 2a medical device.

The following manufacturer field safety notice or medical device alert for this technology has been identified:

US Food and Drug Administration MAUDE Adverse Event Report: Butterfly Network inc. Butterfly iQ charger wireless system charger (September 2020). A potential adverse event report was identified by 1 user. While charging, the ultrasound charging pad melted a port. The report states that the Butterfly iQ+ ultrasound system design prevents the probe from being used for scanning while charging, so this event does not represent a hazard to patients. The investigation is ongoing to identify the root cause.