Recall Z-2316-2024 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE Vingmed Ultrasound As
GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA
| Date | Jul 5, 2024 (initiated May 2, 2024) |
| Status | Open, Classified |
| Reason | GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a slow DICOM Worklist response time, incorrect patient name and demographics can be displayed on the ultrasound scanner screen rather than the intended patient selected by the user. |
| Root cause | Device Design |
| Action | GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 05/02/2024 via letter delivered by traceable means. The notice explained the problem with the device, potential safety issue, and requested the following: "Actions to be taken by Customer/User: You can continue to use your device in accordance with the User Manuals, specifically: 1. After selecting a patient in the DICOM Modality Worklist, make sure to review and confirm that the patient demographics shown on the ultrasound scanner screen during the exam are from the intended patient. 2. In the scenarios |
| Quantity | 7 units |
| Distribution | US: IL, MA, NM, NY, OK, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150087 | Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ult Ge Vingmed Ultrasound AS, Mar 4, 2015 |