GE Vivid Ultrasound Scanner Displays Incorrect Patient Data
GE Vivid ultrasound systems may display incorrect patient names and demographics due to slow DICOM response times, risking patient misidentification during imaging.
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: This is a Class II device recall involving a risk-of-harm product where patient misidentification could occur. No illnesses or injuries have been reported in the source text, which limits the score per the rubric criteria for high-risk situations without reported injury.
Plain-English summary
GE HealthCare is recalling certain Vivid ultrasound systems (Model S70, serial number 001423S70) due to a software issue where slow DICOM Worklist response times cause incorrect patient information to display on the scanner screen.
When DICOM Worklist response times are slow, the affected systems may display incorrect patient names and demographics on the scanner screen, even though the user selected the intended patient. This creates a risk that the wrong patient could be imaged or that patient data could be confused during the ultrasound procedure.
The affected systems were distributed to facilities in Illinois, Massachusetts, New Mexico, New York, and Oklahoma. Clinicians and facilities using the affected Vivid systems should verify patient identity through secondary identification methods before proceeding with any imaging procedure to ensure the correct patient is being scanned.
The recalled product
- Product
- GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW
- Manufacturer
- GE Vingmed Ultrasound As
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- a) H45041SW
- UDI/DI *
- Serial Numbers: 001423S70
Distribution
Part of a larger recall action
This product is one of 2 recalled by GE Vingmed Ultrasound As 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.
See all 2 products in this recall →Related recalls
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