Recalling Firm / Manufacturer

Nicolet Biomedical Div of Viasys Healthcare

Product

BMSI "MicroJack" PN 672-510000 patient interface electrode connection device used during electroencephalography (EEG) /Epilepsy Monitoring evaluations with various EEG monitoring systems. The MicroJack is used with BMSI Models 2000, 3000, 4000, 5000 & 6000, and is used with the BMSI kit upgraded with NicoletOne. Nicolet Biomedical, Inc.

Code Information

Models BMSI 2000, 3000, 4000, 5000 & 6000 and BMSI kit upgraded with NicoletOne.

Reason of Recall

The BMSI "MicroJack" patient interface electrode connection device used with the EEG monitor systems was found to be mis-wired. A complainant alleged that during depth electrode EEG study of a patient in preparation for brain surgery there was an observation that was perceived as non-logical data output.

Date Recall Initiated

July 17, 2007

Action

VIASYS will initiate a field correction for units that have been distributed. The correction consists of testing the units and replacing those that have been found to contain the defect. Method of communication will be by certiified mail to identify consignees and receipt of the communication will be tracked. Letters "Viasys HealthCare Urgent Medical Device Field Correction (Recall)" were sent 7/17/07 to both domestic and international customers. Firm Initiated recall is ongoing.

Contact

N/A

Source of Information

U.S. FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.