Z-0123-2022Class II

EPIQ CVxi Diagnostic Ultrasound Systems

Name: Z-0123-2022 EPIQ CVxi Diagnostic Ultrasound Systems
Creator: Philips Ultrasound Inc
Published: 2021-09-21
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2021-09-21 / Terminated / root cause: software

FDA source

Philips Ultrasound Inc began a recall of EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232 on 2021-09-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0123-2022
Classification: Class II
Status: Terminated
Initiated: 2021-09-21
Posted: 2021-10-16
Terminated: 2024-04-12
Recalling firm: Philips North America LLC
Product: EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
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.
Root cause tag: software
FDA root cause: Software design
Action: On 09/21/21, correction notices were sent to customers. Customers were asked to do the following: Identify affected devices by determining the software version using the following steps: Instructions for how to determine the software version of your EPIQ CVxi Ultrasound System: 1. Power up the system and allow it to complete the boot sequence, 2. Press Support on the right side of the control panel, 3. Under System Management, click System Information, 4. The software version is listed in the Software Information Section. The recalling firm recommends that you disable the secondary screen capture feature (i.e., Image Export Capture Setting) in the EchoNavigator system settings to prevent the system from becoming unresponsive due to this issue. The secondary screen recording feature is enabled as a default setting for all EchoNavigator based TEE exams. A recalling firm Field Service Engineer will contact you to schedule a software update to permanently resolve the issue. Please promptly complete and return the attached response form. If there are additional questions, contact your local firm representative: 1-800-722-9377 and reference FCO79500548.
Quantity in commerce: 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
Product codes and lots: Software Versions: 6.0, 7.0, 7.0.3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0123-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0123-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-27	2021-10-15

Product code IYN

K200304Class IIEPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. / cleared 2020-03-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)