Recall – Inadvertent error with ultrasound system

Company: Philips Ultrasound Inc
Date of Enforcement Report: 10/27/2021
Class II

PRODUCT

EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232

Recall Number: Z-0123-2022

REASON

Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive system, necessitating system restart, which could lead to therapy/treatment delay and/or unnecessary therapy/treatment. Can occur during ultrasound-guided TEE with EchoNavigator, if secondary screen capture is enabled and user presses other system buttons before secondary capture completed.

RECALLING FIRM/MANUFACTURER

Philips Ultrasound Inc on 9/21/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

107

DISTRIBUTION

U.S. Nationwide and International

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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