FDA Medical Device Recalls (openFDA)
Philips Ultrasound Inc: EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
- Recall number
- Z-0123-2022
- Recalling firm
- Philips Ultrasound Inc
- Product
- EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
- Status
- Terminated
- Initiated
- 2021-09-21
- Posted
- not on file
- Terminated
- 2024-04-12
- 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.
- 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
- 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
- Lot, serial or model codes
- Software Versions: 6.0, 7.0, 7.0.3
- 510(k) numbers
- K200304
- PMA numbers
- not on file
- Product code
- IYN
- Firm FEI
- 3019216
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28