Company:CareFusion 209 Inc.
Date of Enforcement Report 3/28/12
Class l:
PRODUCT
1) NicoletOne Software v 5.60.2-5.71.4 with Cortical Stimulator License, Catalog/Part Number: 828-056600 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 # Z-0799-2012;
2) 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 # Z-0800-2012;
3) 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 # Z-0801-2012
REASON
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 Stimulator Control Unit and C64 SSU Amplifier have the potential to develop a short circuit.
RECALLING FIRM/MANUFACTURER
CareFusion 209 Inc., Middleton, WI, by letter dated October 5, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
167 units
DISTRIBUTION
Nationwide and Internationally
