Philips Ultrasound Inc EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

AZ, CA, CO, IL, IN, IA, KY, LA, MD, MI, NJ, NY, NC, OH, PA, TN, TX, WI