Recall Z-0865-2024— GE HEALTHCARE AUSTRIA GMBH & CO

Name: FDA recall Z-0865-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-22

Class II · Ongoing

Class II FDA medical device recall by GE HEALTHCARE AUSTRIA GMBH & CO, initiated 2023-12-22. It names one FDA 510(k) clearance: K160184. Product: GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis. Reason: 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..

Recalling firm: GE HEALTHCARE AUSTRIA GMBH & CO
Classification: Class II
Status: Ongoing
Initiated: 2023-12-22
Firm location: Pfaffing, Austria

510(k) clearances named in this recall

1 on FDA's record

K160184 — Voluson S6, Voluson S8, Voluson S10GE Healthcare·cleared 2016-02-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.