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.
This recall has been terminated (originally issued September 20, 2007).
- Recall Initiated
- July 17, 2007
- Posted
- September 20, 2007
- Terminated
- December 10, 2011
- Recall Number
- Z-1225-2007
- Quantity
- 2102
- Firm Location
- Madison, WI
- Official Source
- View on FDA website ↗
Reason for 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.
Distribution
Worldwide, including USA, ISRAEL, LITHUANIA, RUSSIA, FRANCE, IRELAND, UNITED KINGDOM , SPAIN, YEMEN, JAPAN, TAIWAN, KOREA, CHINA, SAUDI ARABIA, HONG KONG, INDIA, COLOMBIA, BRAZIL, GERMANY, CANADA, DENMARK, ITALY, MEXICO, and THAILAND.
Lot / Code Info
Models BMSI 2000, 3000, 4000, 5000 & 6000 and BMSI kit upgraded with NicoletOne.
Root Cause
Other
Action Taken
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.