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Philips Ultrasound Inc Recall 88728

Description: EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232

Philips Ultrasound Inc Recall 88728 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0123-2022
Event ID88728
Event DescriptionEPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Product TypeDevices
DistributionUS: MI, AZ, IA, TN, OH, CO, WI, NY, NJ, NC, LA, IL, CA, KY, IN, MD, TX, PA. OUS: Denmark, Latvia, Belgium, Hungary, Argentina, Canada, Spain, Germany, Greece, Korea, Republic of Japan, France, Australia, Egypt, Switzerland, Italy, Senegal, Israel, Indonesia, Netherlands, Hong Kong, United Kingdom, Poland, Finland, India, New Zealand
Recall ReasonUltrasound 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.
Device Classification20211027
Device Code InfoSoftware Versions: 6.0, 7.0, 7.0.3
Center Classification Date20211015
Recall Initiation Date20210921
Recalling FirmPhilips Ultrasound Inc
Initial Notification Letter
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