Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

GE Voluson IC9-RS intracavitary probes Recalled by GE HEALTHCARE AUSTRIA GMBH & CO Due to GE HealthCare has become aware of an issue...

Date: December 22, 2023
Company: GE HEALTHCARE AUSTRIA GMBH & CO
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GE HEALTHCARE AUSTRIA GMBH & CO directly.

Affected Products

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

Quantity: 12004 units

Why Was This 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.

Where Was This Sold?

worldwide

About GE HEALTHCARE AUSTRIA GMBH & CO

GE HEALTHCARE AUSTRIA GMBH & CO has 1 total recall tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report