GE Healthcare Recalls Vivid Ultrasound Systems Due to Patient Selection Error
GE Healthcare is recalling Vivid Ultrasound systems because slow search times can cause operators to select the wrong patient, potentially leading to misdiagnosis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the defect could lead to misdiagnosis, but the source explicitly states that no injuries have been reported, fitting the criteria for a score of 3.
Plain-English summary
GE Healthcare, LLC is recalling specific models of Vivid Ultrasound systems, including the S60, S70, S60N, and S70N. The recall involves 396 units, with 67 located in the United States and 329 outside the U.S.
The recall is due to a software issue where the system may incorrectly select a patient other than the intended one when the DICOM Worklist search response time is slow. This can result in incorrect patient information appearing on the screen during an exam. If the operator does not detect the error, images from the actual patient may be stored under the wrong patient's record, which could lead to misdiagnosis.
The affected units are distributed across numerous countries, including the United Kingdom, United Arab Emirates, Turkey, Thailand, and many others. GE Healthcare has reported that there have been no injuries associated with this issue. Users should contact GE Healthcare for instructions on how to resolve the software defect.
The recalled product
- Product
- Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.
- Manufacturer
- GE Healthcare, LLC
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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