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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 Recall
Bravo Multimodality system
see related information
Date Posted September 21, 2008
Recall Status1 Terminated on October 13, 2010
Recall Number Z-2389-2008
Recall Event ID 48758
Premarket Notification
510(K) Number
K991054 
Product Classification Full-Montage Standard Electroencephalograph - Product Code GWQ
Product NicoletOne photic adapter cable 085-463700
Code Information 085-463700
Recalling Firm/
Manufacturer
Cardinal Health NeuroCare Division
5225 Verona Rd
Madison, Wisconsin 53711-4497
Consumer Instructions Contact the recalling firm for information
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action A "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 Commerce 92
Distribution CA 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 Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GWQ and Original Applicant = NICOLET BIOMEDICAL, INC.
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