Recall Z-0865-2024 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE HEALTHCARE AUSTRIA GMBH & CO
GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
| Date | Jan 30, 2024 (initiated Dec 22, 2023) |
| Status | Open, Classified |
| Reason | GE HealthCare has become aware of an issue with certain IC9-RS ultrasound probes (see Affected Products List) that can result in a double image artifact creating a ghost image with realistic features. An unrecognized artifact may lead to misdiagnosis. |
| Root cause | Device Design |
| Action | GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 12/22/2023 via letter delivered using traceable means. The notice explained the issue with the device, safety issue, and requested the following actions be taken: 1. Ensure all potential users in your facility are made aware of this correction notification and the recommended actions. 2. You can continue to use your ultrasound system with all other probes. 3. Upon receipt of the letter, verify if your IC9-RS probe is functioning correctly prior to use by performing the Double Image artifact test provided in |
| Quantity | 12004 units |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160184 | Voluson S6, Voluson S8, Voluson S10 GE Healthcare, Feb 25, 2016 |