FDA (Devices) recall action 76805
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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.
The agency’s own wording, quoted from the enforcement report.
GE Healthcare is recalling Vivid Ultrasound systems because slow search times can cause operators to select the wrong patient, potentially leading to misdiagnosis.
GE Healthcare is recalling Vivid E95, E90, and E80 ultrasound systems because slow search times can cause operators to select the wrong patient, potentially leading to misdiagnosis.