Z-0801-2012

Nicolet C64 Stimulus Switching Unit (SSU Amplifier), Catalog/ Part Numbers: 382-610800, 688-624200...

Name: Z-0801-2012 Nicolet C64 Stimulus Switching Unit (SSU Amplifier), Catalog/ Part Numbers: 382-610800, 688-624200...
Creator: CareFusion 209 Inc.
Published: 2011-10-05
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2011-10-05 / Terminated / root cause: manufacturing process

FDA source

CareFusion 209 Inc. began a recall of Nicolet C64 Stimulus Switching Unit (SSU Amplifier), Catalog/ Part Numbers: 382-610800, 688-624200, 688-624300, 842-687900, 672-610800F. Product Usage: The SSU... on 2011-10-05. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0801-2012
Status: Terminated
Initiated: 2011-10-05
Posted: 2012-01-26
Terminated: 2012-05-21
Recalling firm: Medtronic, Inc.
Product: Nicolet C64 Stimulus Switching Unit (SSU Amplifier), Catalog/ Part Numbers: 382-610800, 688-624200, 688-624300, 842-687900, 672-610800F. 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.
Product code: GYC Electrode, Cortical
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
Root cause tag: manufacturing process
FDA 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 in commerce: 80 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.
Product codes and lots: C64SSU090058 C64SSUS100002-0 C64SSU090040 C64SSU090015 C64SSU090027 C64SSU090025 C64SSU090025 C64SSU090029 C64SSU100096-0 C64SSU090068 C64SSU090058 C64SSUS100001-0 C65SSU100074 C64SSU090053 C64SSU090011 C64SSU100086-0 C65SU090054 C64SSU100098-0 C64SSU090028-1 C64SSU090028 C64SSU090028 C64SSU090030 C64SSU090031 C64SSU090067-1 C64SSU100088-0 C64SSU100079 C54SSU090035 C64SSU090044 C64SSU100091-0 CS64SSU090049 C64SSU090064 C64SSU090045 C64SSU100076 C64SSU090062 C64SSU100099-0 & C64SSU100104-0 C64SSU100069 C64SSU090033 C64SSU100073 C64SSU100101-0 C64SSU100093-1 C64SSU100082-0 C64SSU090036 C64SSU090022 C64SSU090051-1 CS64SSU090049 C64SSU090038 C64SSU100097-1, C64SSU100105-0, C64SSU100110-0 C64SSU090048 C64SSU090055-1 C64SSU090066 C64SSU100100-0 C64SSU100081-0 C64SSU100084-0 C564SSU090061-1 C64SSU100107-0 C64SSU090057-1 C54SSU100087-0 CS09160157 CS-09350163 C64SSU100096-0

Product code GYC

K072964Class IINicolet Cortical StimulatorCardinal Health, Inc. / cleared 2008-12-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)