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.
|