FDAFDA · Alimentos y medicamentos·N.º oficial Z-1952-2012
CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5), Ref. 5350925. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices
Publicado el 18 de julio de 2012 · Inicio del retiro: 7 de mayo de 2012
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.
Qué hacer
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Detalles del retiro
- Fabricante
- Civco Medical Instruments Inc
- Distribuidor
- Worldwide Distribution - USA including WI, CA, MA, IN, WA, and NJ. Foreign distribution was made to Germany, Canada, Denmark, Hong Kong, Ukraine, Japan, Italy, Korea, and France.
- Lote
- Lot numbers M560850, M682770, M725050, M725060, M751430, M753340, M753350, M753360, M753370, M770940, M779830, M779840, M790710, M790720, M790730, M790740, M798560, M813890, and M840810.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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