FDA recall Z-0865-2024

GE HEALTHCARE AUSTRIA GMBH & CO · Class II · device

Product

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

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

Key facts

Status: Ongoing
Initiation date: 2023-12-22
Report date: 2024-02-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Pfaffing, Austria

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0865-2024