GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0865-2024.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0865-2024.
Recall ongoing. Follow firm instructions.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0865-2024.
GE HEALTHCARE AUSTRIA GMBH & CO
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Ge Healthcare Austria Gmbh & Co Recall FAQ
Ge Healthcare Austria Gmbh & Co is the subject of a diagnostic devices safety report: GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis. The notice was published on December 22, 2023 by the U.S. Food and Drug Administration (FDA). Approximately 12,004 units are potentially affected.