Oct

2008

Cl Il NicoletOne 5.30.2 Software

Company: Cardinal Health NeuroCare Division
Date of Enforcement Report 10/22/2008
Class:ll

PRODUCT
NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. The product is used for extended monitoring of EEG in a hospital setting. The system provides connection between the patient room EEG acquisition system and central control room, Recall # Z-2459-2008

REASON
NicoletOne 5.30.2 Software when used with CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. The 3rd party room relay connected to the A2 wall plate does not always activate if the patient event button connected to the CSeries Amplifier is pressed twice within one second.

RECALLING FIRM/MANUFACTURER
Cardinal Health NeuroCare Division, Madison, WI, by letter dated June 23, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
274 units

DISTRIBUTION
Nationwide and Internationally

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl Il NicoletOne 5.30.2 Software

Amy Sellers

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