FDA Medical Device Recalls (openFDA)
CareFusion 209 Inc.: Nicolet Cortical Stimulator Control Unit, Catalog/Part Number: 982A0558 Product Usage: The SSU Amplifier is used with the Cortical Stimulator Control unit which is used for functional brain mapping procedures during treatment of patients with seizure disorder and brain tumors, providing stimulation via electrode pairs or a hand held bipolar probe.
- Recall number
- Z-0800-2012
- Recalling firm
- CareFusion 209 Inc.
- Product
- Nicolet Cortical Stimulator Control Unit, Catalog/Part Number: 982A0558 Product Usage: The SSU Amplifier is used with the Cortical Stimulator Control unit which is used for functional brain mapping procedures during treatment of patients with seizure disorder and brain tumors, providing stimulation via electrode pairs or a hand held bipolar probe.
- Status
- Terminated
- Initiated
- 2011-10-05
- Posted
- 2012-01-26
- Terminated
- 2012-05-21
- Reason
- 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
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 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, ISRAEL, KOREA, NORWAY, PORTUGAL, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, RUSSIA and UNITED KINGDOM.
- Lot, serial or model codes
- CS09350168 CS09350168 CS-09140115 CS-09140135 CS-09140114 CS09160139 CS-09160155 CS-09070102R CS-09350179 CS-09350177 CS-09160147 CS-09160113 CS09140119 CS0916148 CS09350165 CS09140132 CS-09140122 Unknown Unknown CS-09350173 CS-09160136 CS-09160153 CS09350181 CS09350183 CS-09070109 RA090266M CS-09350171 C64SSU100081-0 CS-09350172 CS09140128 CS-09350174 CS-09350170 CS-09140111 Unknown CS-09160152 Unknown Unknown CS-09160141 CS-09160144 Unknown Unknown CS-09140117 CS09140112 CS-09160158 CS-09160123 CS-09160137 CS-09160126 CS-09140127 CS09350164 CS09140125
- 510(k) numbers
- ["K072964"]
- PMA numbers
- not on file
- Product code
- GYC
- Firm FEI
- 3010611950
- Firm city
- Middleton
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28