Recall Z-0123-2022— Philips Ultrasound Inc
Class II · Terminated
Class II FDA medical device recall by Philips Ultrasound Inc, initiated 2021-09-21, terminated 2024-04-12. It names one FDA 510(k) clearance: K200304. Product: EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232. 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
- Philips Ultrasound Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-09-21
- Terminated
- 2024-04-12
- Firm location
- Bothell, WA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.