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U.S. Department of Health and Human Services

Class 2 Device Recall Bravo Multimodality system

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 Class 2 Device Recall Bravo Multimodality systemsee related information
Date Initiated by FirmJune 05, 2008
Date PostedSeptember 21, 2008
Recall Status1 Terminated 3 on October 13, 2010
Recall NumberZ-2389-2008
Recall Event ID 48758
510(K)NumberK991054 
Product Classification Electroencephalograph - Product Code GWQ
ProductNicoletOne photic adapter cable 085-463700
Code Information 085-463700
FEI Number 3010611950
Recalling Firm/
Manufacturer		 Cardinal Health NeuroCare Division
5225 Verona Rd
Madison WI 53711-4497
For Additional Information Contact
608-271-3333
Manufacturer Reason
for Recall		Cardinal Health NeuroCare is implementing a voluntary field correction to replace a quantity of photic adapter cables, part number 085-463700, used to connect the NicLED Photic Strobe option, part number 698-625500, with NicoletOne EEG system. The photic adapter cable has a wiring error which delivers a reduced voltage and results in a decreased intensity of the NicLED photic. This reduced intensi
FDA Determined
Cause 2		Nonconforming Material/Component
ActionA "Cardinal Health Urgent: Medical Device Correction" letter was sent to consignees. The letter described the product and the problem. The consignees were asked to confirm completion of the cable exchange by returning an information card. If you have questions, contact Cardinal Health (formerly VIASYS) NeuroCare Technical Support Group at 1-800-356-0007 (US), 608-273-5000 (OUS) or email shane.sawall@cardinalhealth.com.
Quantity in Commerce92
DistributionCA FL GA ID IN LA MD ME MI MO NC NY PA TN TX WA WI China Denmark Indonesia Japan Korea Mexico Netherlands Russia Saudi Arabia Slovenia
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GWQ
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