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