FDAFDA · Food and drugs·Recall number Z-1954-2012
CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 610-1066. 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
Published July 18, 2012 · Recall initiated: May 7, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Civco Medical Instruments Inc
- Distributor
- 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.
- Lot
- Lot numbers M436540, M468460, M469640, M495160, M495190, M523420, M524580, M555880, M563330, M577940, M590400, M597880, M643870, M673080, M685650, M708280, M717280, M726110, M726130, M736410, M782740, M799860, M817860, and M840610.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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