FDA Device recall Z-0123-2022
EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
- FDA Device
- Class II
- terminated
- Published 2021-10-27
On 2021-10-27 the FDA classified a Class II recall of EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232 by Philips Ultrasound, citing ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive system, necessitating system restart, which could lead to therapy/treatm….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0123-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-09-21 |
| Published | 2021-10-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Ultrasound |
| Distribution | AZ, CA, CO, IA, IL, IN, KY, LA, MD, MI, NC, NJ, NY, OH, PA, TN, TX, WI |
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.
Identifiers
| code_info | Software Versions: 6.0, 7.0, 7.0.3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0123-2022%22
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