05
May
2010

Cl Il NicoletOne vEEG System

0

CompanyCarefusion
Date of Enforcement Report 4/28//2010
Class:ll

PRODUCT
NicoletOne vEEG System. Recall # Z-1256-2010

REASON
CareFusion NeuroCare is voluntarily implementing a field correction to delete certain NicoletOne software protocols, which users may interpret incorrectly when conducting patient evaluations. The field correction involves providing users with instructions for removing the subject protocols and verifying the deletion has been properly conducted. CareFusion NeuroCare believes that the products in the field with the original configuration are not likely to cause any adverse events for patients..

RECALLING FIRM/MANUFACTURER
CareFusion, Middleton, WI, by letter dated March 3, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2984 US; 3147 OUS

DISTRIBUTION
Nationwide and Internationally

About the author

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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