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U.S. Department of Health and Human Services

Class 1 Device Recall NicoletOne Software

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  Class 1 Device Recall NicoletOne Software see related information
Date Initiated by Firm October 05, 2011
Date Posted January 26, 2012
Recall Status1 Terminated 3 on May 21, 2012
Recall Number Z-0799-2012
Recall Event ID 60223
510(K)Number K072964  
Product Classification Electrode, cortical - Product Code GYC
Product NicoletOne Software v 5.60.2-5.71.4 with Cortical Stimulator License, Catalog/Part Number: 828-056600

Product Usage:
The SSU Amplifier is used with the Cortical Stimulator Control unit which is used for functional brain mapping procedures during treatment of patients with seizure disorder and brain tumors, providing stimulation via electrode pairs or a hand held bipolar probe.
Code Information n/a
Recalling Firm/
Manufacturer		 CareFusion 209 Inc.
1850 Deming Way
Middleton WI 53562-3530
For Additional Information Contact
608-829-8500
Manufacturer Reason
for Recall		 CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation the electrode annotation label may be incorrect on the screen and in the report when the current is correctly delivered through the selected electrodes. Also, it has been determined that the stimulus cable connection in the Cortical S
FDA Determined
Cause 2		 Nonconforming Material/Component
Action CareFusion sent an "Urgent: Field Safety Corrective Action Notification" letter dated October 5, 2011 to all affected consignees. The letter described the product, the problem and urgent actions to be taken. Consignees were advised to immediately provide their customers with the attached customer notification letter. Consignees were instructed to complete and return the Verification Form enclosed in the notice. For questions on this matter call 1-800-356-0007 ext. 5129.
Quantity in Commerce 35 units
Distribution Worldwide Distribution - USA (nationwide) including the states of: AR, CA, FL, GA, HI, KY, MI, MO, NY, TX and WA and the countries of: CANADA, CHILE, CHINA, COATIA, DENMARK, FRANCE, GERMANY, INDIA, ISRAEL, KOREA, NORWAY, PORTUGAL, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, RUSSIA and UNITED KINGDOM.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GYC and Original Applicant = CARDINAL HEALTH, INC.
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