FDADecember 22, 2023device
GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
GE HealthCare has become aware of an issue with certain IC9-RS ultrasound probes (see Affected Products List) that can result in a double image artifact creating a ghost image with realistic features. An unrecognized artifact may lead to misdiagnosis.
What to do
FDA enforcement status: Ongoing
Brands named
ge healthcare austria gmbh
Recall history
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