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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

GE HEALTHCARE AUSTRIA GMBH & CO: Voluson IC9-RS Ultrasound Probes Recalled Due to Misdiagnosis Risk

Agency Publication Date: January 30, 2024
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Summary

GE Healthcare has recalled 12,004 Voluson IC9-RS intracavitary ultrasound probes, Model J48691PJ, used for diagnostic medical imaging. These probes can produce a realistic double or "ghost" image during scans, which can be mistaken for actual anatomical features. If this artifact is not recognized by a medical professional, it could lead to an incorrect medical diagnosis. Consumers and healthcare facilities should contact their healthcare provider or GE Healthcare for further instructions regarding affected units.

Risk

The probes create a realistic image artifact that duplicates anatomical features. This malfunction can cause clinicians to misidentify medical conditions, potentially leading to incorrect patient treatments or unnecessary procedures based on non-existent features shown in the scan.

What You Should Do

  1. Identify your equipment by looking for the GE Voluson IC9-RS intracavitary probe, Model Number J48691PJ.
  2. Check the serial number on your probe's identification label and compare it against the extensive list of affected units, which includes serial numbers such as 1222552WX0, 1263125WX5, 1066771WX5, 1191105WX4, and approximately 12,000 others.
  3. Verify if your device matches UDI/DI 00840682105026112303002 as listed in the recall notification.
  4. Be aware of the potential for realistic ghost images during ultrasound procedures which may mimic actual clinical features.
  5. Contact your healthcare provider or GE Healthcare directly to receive guidance on corrective actions and equipment evaluation.
  6. For further information or to report concerns, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare professional notification and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: GE Voluson IC9-RS intracavitary probes
Model / REF:
J48691PJ
Lot Numbers (2756):
UDI/DI 00840682105026112303002
1222552WX0
1263125WX5
1066771WX5
1191105WX4
1098079WX5
1108318WX5
1213744WX4
1101633WX4
1255114WX9
1278312WX2
1148860WX8
1194288WX5
1245514WX3
1260097WX9
1086878WX4
1193938WX6
1214142WX0
1214224WX6
1250333WX0
1148798WX0
967787WX3
1240563WX5
1086837WX0
1056904WX4
1240504WX9
1240523WX9
1078218WX3
1164537WX1
1164543WX9
1164578WX5
1165280WX7
1226207WX7
1200650WX8
1204921WX9
1209228WX4
1209233WX4
1209242WX5
1209249WX0
1194302WX4
1083859WX7
1136238WX1
1232511WX4
965764WX4
1102421WX3
1108360WX7
1159168WX2
1159192WX2
1159296WX1
1164485WX3

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93727
Status: Active
Manufacturer: GE HEALTHCARE AUSTRIA GMBH & CO
Sold By: Authorized GE Healthcare medical equipment distributors
Manufactured In: Austria
Units Affected: 12004 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.