Recall Z-1780-2017 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE Healthcare, LLC
Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.
| Date | Mar 10, 2017 |
| Status | Terminated |
| Reason | GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist search response time is slow. This issue is limited to certain Vivid Ultrasound systems and can result in the incorrect patient information showing on the screen during the exam. If not detected by the operator, images from the actual (intended) patient will be stored under the incorrect patient after the exam. This issue could lead to misdiagnosis. There have been no injuries reported because of this issue. |
| Root cause | Software design |
| Action | Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 76164,76168 dated March 10, 2017. The letter was addressed to Hospital Administrators / Risk Manager, Biomedical Engineering, & Managers of Radiology / Managers of Cardiology. The letter described the safety Issue, Safety Instructions, Affected Product Detail, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. |
| Quantity | 396 (67 US; 329 OUS) |
| Distribution | United Kingdom, United Arab Emirates, Turkey, Thailand, Switzerland, Sweden, Spain, South Africa, Slovenia, Saudi Arabia, Russia, Romania, Portugal, Poland, Philippines, Norway, New Zealand, New Caledonia, Netherlands, Myanmar, Kuwait, Korea (Republic of), Japan, Italy, ISRAEL, Ireland, Iran, India |
| 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 |