Recall Z-2389-2008 ยท GWQ Full-Montage Standard Electroencephalograph
Cardinal Health NeuroCare Division
NicoletOne photic adapter cable 085-463700
| Date | Sep 21, 2008 (initiated Jun 5, 2008) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991054 | BRAVO MULTI-MODALITY SYSTEM Nicolet Biomedical, Inc., Nov 3, 1999 |