GE HEALTHCARE AUSTRIA GMBH & CO recalls GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis

Recall date

December 22, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0865-2024

FDA classification

Class II

Brand / firm

GE HEALTHCARE AUSTRIA GMBH & CO

Sold / distributed

worldwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis