Nicolet Cortical Stimulator Control Unit, Catalog/Part Number: 982A0558 Product Usage: The SSU Amplifier is used with th
FDA device recall Z-0800-2012 · posted 2012-01-26 · Terminated
Recall details
- Recalling firm
- CareFusion 209 Inc.
- Reason for recall
- CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation the electrode annotation label may be incorrect on the screen and in the report when the current is correctly delivered through the selected electrodes. Also, it has been determined that the stimulus cable connection in the Cortical S
- Action taken
- CareFusion sent an "Urgent: Field Safety Corrective Action Notification" letter dated October 5, 2011 to all affected consignees. The letter described the product, the problem and urgent actions to be taken. Consignees were advised to immediately provide their customers with the attached customer notification letter. Consignees were instructed to complete and return the Verification Form enclosed in the notice. For questions on this matter call 1-800-356-0007 ext. 5129.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GYC
- Quantity affected
- 52 units
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of: AR, CA, FL, GA, HI, KY, MI, MO, NY, TX and WA and the countries of: CANADA, CHILE, CHINA, COATIA, DENMARK, FRANCE, GERMANY, INDIA, IS
- Date initiated
- 2011-10-05
- Date posted
- 2012-01-26
- Date terminated
- 2012-05-21
- Location
- Middleton, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NICOLET CORTICAL STIMULATOR (K072964) | Cardinal Health, Inc. | 2008-12-30 |