EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Reported: October 27, 2021 Initiated: September 21, 2021 #Z-0123-2022
Product Description
EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Reason for Recall
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.
Details
- Recalling Firm
- Philips Ultrasound Inc
- Units Affected
- 107
- Distribution
- US: 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
- Location
- Bothell, WA
Frequently Asked Questions
What product was recalled? ▼
EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232. Recalled by Philips Ultrasound Inc. Units affected: 107.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 27, 2021. Severity: Moderate. Recall number: Z-0123-2022.
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