Recall Z-0123-2022 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Philips Ultrasound Inc
EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
| Date | Sep 21, 2021 |
| Status | Terminated |
| 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 c |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200304 | EPIQ Diagnostic Ultrasound System Philips Ultrasound, Inc., Mar 6, 2020 |