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

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