NicoletOne photic adapter cable 085-463700
FDA device recall Z-2389-2008 · posted 2008-09-21 · Terminated
Recall details
- Recalling firm
- Cardinal Health NeuroCare Division
- 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
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GWQ
- Quantity affected
- 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
- Date initiated
- 2008-06-05
- Date posted
- 2008-09-21
- Date terminated
- 2010-10-13
- Location
- Madison, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRAVO MULTI-MODALITY SYSTEM (K991054) | Nicolet Biomedical, Inc. | 1999-11-03 |