EPIQ CVxi Diagnostic Ultrasound Systems — Class II medical device recall Z-0123-2022
Terminated recall by Philips Ultrasound Inc, reported 2021-10-27, distributed in AZ, CA, CO, IA, IL, IN, KY, LA…. Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive sys
| Recall number | Z-0123-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Ultrasound Inc, Bothell, WA, United States |
| Recall initiated | 2021-09-21 |
| Classified | 2021-10-15 |
| Reported by FDA | 2021-10-27 |
| Terminated | 2024-04-12 |
| Distributed | AZ, CA, CO, IA, IL, IN, KY, LA, MD, MI, NC, NJ, NY, OH, PA, TN, TX, WI |
| Countries outside the US | AR, AU, BE, CA, CH, DE, DK, EG, ES, FI, FR, GB, GR, HK, HU, ID, IL, IN, IT, JP, KR, LV, NL, NZ, PL |
| Quantity | 107 |
| Reason classes | software |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0123-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.