Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Bravo Multimodality system

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Bravo Multimodality system see related information
Date Initiated by Firm June 05, 2008
Date Posted September 21, 2008
Recall Status1 Terminated 3 on October 13, 2010
Recall Number Z-2389-2008
Recall Event ID 48758
510(K)Number K991054  
Product Classification 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 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
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 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 = GWQ and Original Applicant = NICOLET BIOMEDICAL, INC.
-
-