FDA-Device2024-02-07Class II
GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
GE HEALTHCARE AUSTRIA GMBH & CO
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.
Sold states
worldwide
Affected count
12004 units
Manufactured in
Tiefenbach 15, Pfaffing, Austria
Products
GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0865-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief