CareFusion 209 Inc.: 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.

Recall number

Z-0801-2012

Recalling firm

CareFusion 209 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.

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

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.

Lot, serial or model codes

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

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

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

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