Z-1225-2007

BMSI "MicroJack" PN 672-510000 patient interface electrode connection device used during...

Name: Z-1225-2007 BMSI "MicroJack" PN 672-510000 patient interface electrode connection device used during...
Creator: Nicolet Biomedical Div of Viasys Healthcare
Published: 2007-07-17
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2007-07-17 / Terminated

FDA source

Nicolet Biomedical Div of Viasys Healthcare began a recall of BMSI "MicroJack" PN 672-510000 patient interface electrode connection device used during electroencephalography (EEG) /Epilepsy Monitoring evaluations with... on 2007-07-17. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1225-2007
Status: Terminated
Initiated: 2007-07-17
Posted: 2007-09-20
Terminated: 2011-12-10
Recalling firm: Medtronic, Inc.
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.
Product code: GWQ Full-Montage Standard Electroencephalograph
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.
FDA root cause: Other
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.
Quantity in commerce: 2102
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.
Product codes and lots: Models BMSI 2000, 3000, 4000, 5000 & 6000 and BMSI kit upgraded with NicoletOne.

Product code GWQ

K891405Class IIBms-2000 Mobile EEG SystemBuckman Co., Inc. / cleared 1989-08-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)