Philips Ultrasound Inc Recall 88728
Description: EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Philips Ultrasound Inc Recall 88728 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0123-2022 |
| Event ID | 88728 |
| Event Description | EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232 |
| Product Type | Devices |
| 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 |
| Quantity | 107 |
| Recall 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. |
| Device Classification | 20211027 |
| Device Code Info | Software Versions: 6.0, 7.0, 7.0.3 |
| Center Classification Date | 20211015 |
| Recall Initiation Date | 20210921 |
| Recalling Firm | Philips Ultrasound Inc |
| Initial Notification | Letter |
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