Events

Recall of Nicolet C64 Stimulus Switching Unit (SSU Amplifier),

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CareFusion 209 Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60223
  • Event Risk Class
    Class 1
  • Event Number
    Z-0801-2012
  • Event Initiated Date
    2011-10-05
  • Event Date Posted
    2012-01-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104817
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Electrode, cortical - Product Code GYC
  • 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.
  • 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.

Device

Nicolet C64 Stimulus Switching Unit (SSU Amplifier),
  • Model / Serial
    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 Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    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.
  • Manufacturer
    CareFusion 209 Inc.

Manufacturer

CareFusion 209 Inc.
  • Manufacturer Address
    CareFusion 209 Inc., 1850 Deming Way, Middleton WI 53562-3530
  • Source
    USFDA