Reported Feb 7, 2024 · Ongoing
GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
Ge Healthcare Austria GmbH & Co.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE HEALTHCARE AUSTRIA GMBH & CO · Tiefenbach 15 · Pfaffing · N/A
Is this the product you have?
- GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
- Lot codes and dates
- UDI/DI 00840682105026112303002
- Serial Numbers
2,718 of 2,718 codes
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
- Amount recalled
- 12004 units
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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