Class II

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

GE HEALTHCARE AUSTRIA GMBH & CO · December 22, 2023

Reason for Recall

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.

Distribution

worldwide

Quantity Affected

12004 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0865-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.