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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Product Detail

Product Description 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
Recall Number Z-1954-2012
Classification Class II
Code Info 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.
Product Distributed Qty 100 kits
Reason For Recall The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.

Event Detail

Event Id 61793
Product Type Devices
Status Ongoing
Recalling Firm Civco Medical Instruments Inc
City Kalona
State IA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-07
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern 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.