BMSI "MicroJack" PN 672-510000 patient interface electrode connection device used during electroencephalography (EEG) /E
FDA device recall Z-1225-2007 · posted 2007-09-20 · Terminated
Recall details
- Recalling firm
- Nicolet Biomedical Div of Viasys Healthcare
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GWQ
- Quantity affected
- 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, DEN
- Date initiated
- 2007-07-17
- Date posted
- 2007-09-20
- Date terminated
- 2011-12-10
- Location
- Madison, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BMS-2000 MOBILE EEG SYSTEM (K891405) | Buckman Co., Inc. | 1989-08-02 |