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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 Vet
Medical Devices/Diagnostic Equipment

CareFusion: NicoletOne vEEG Systems Recalled Due to Software Protocol Errors

Agency Publication Date: March 26, 2010
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Summary

CareFusion is recalling 6 units of the NicoletOne vEEG System because certain software protocols may be misinterpreted by users during patient evaluations. This defect involves specific software settings that could lead to incorrect clinical assessments. The recall involves a field correction to delete the problematic protocols and verify they have been removed from the systems. These units were distributed in Florida, New Jersey, and Pennsylvania.

Risk

Incorrect interpretation of software protocols during a patient evaluation can lead to diagnostic errors or improper medical decisions. This could potentially result in delayed or inappropriate treatment for patients undergoing neurological monitoring.

What You Should Do

  1. Identify if you have the NicoletOne vEEG System (Recall #: V-061-2010) manufactured by VIASYS Healthcare, Inc.
  2. Follow the specific field correction instructions provided by CareFusion to delete the subject software protocols from your NicoletOne system.
  3. Verify that the deletion of the identified protocols has been properly conducted according to the manufacturer's verification steps.
  4. Contact your healthcare provider or CareFusion at 1850 Deming Way, Middleton, Wisconsin, 53562, for further instructions regarding the software update and potential refund or service questions.
  5. For additional questions, contact the FDA at 1-888-INFO-FDA (1-888-463-6332).

Your Remedy Options

๐Ÿ“‹Other Action

Field correction to delete software protocols

How to: Follow provided instructions to remove subject protocols and verify the deletion has been properly conducted.

Affected Products

Product: NicoletOne vEEG System, VIASYS Healthcare, Inc.
Model:
V-061-2010

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 55071
Status: Resolved
Manufacturer: CareFusion
Manufactured In: United States
Units Affected: 6 units
Distributed To: Florida, New Jersey, Pennsylvania

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