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GE HEALTHCARE AUSTRIA GMBH & CO recalls GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
Recalled February 7, 2024 · FDA recall Z-0865-2024 · GE HEALTHCARE AUSTRIA GMBH &
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. · FDA Class II
Units
12004 units
Sold at
worldwide
Description
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.
Product
GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
Manufacturer(s)
GE HEALTHCARE AUSTRIA GMBH & CO
Made in
Austria
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →