||September 21, 2008
||Terminated on October 13, 2010
|Recall Event ID
Full-Montage Standard Electroencephalograph - Product Code GWQ
||NicoletOne photic adapter cable 085-463700
|Cardinal Health NeuroCare Division
5225 Verona Rd
Madison, Wisconsin 53711-4497
|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
|COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
||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 firstname.lastname@example.org.
|Quantity in Commerce
|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)s with Product Code = GWQ and Original Applicant = NICOLET BIOMEDICAL, INC.