Recall Z-1954-2012— Civco Medical Instruments Inc

Name: FDA recall Z-1954-2012
Creator: U.S. Food and Drug Administration
Published: 2012-05-07

Class II · Terminated

Class II FDA medical device recall by Civco Medical Instruments Inc, initiated 2012-05-07, terminated 2015-01-07. It names one FDA 510(k) clearance: K092619. Product: 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. Reason: The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device..

Recalling firm: Civco Medical Instruments Inc
Classification: Class II
Status: Terminated
Initiated: 2012-05-07
Terminated: 2015-01-07
Firm location: Kalona, IA, United States

510(k) clearances named in this recall

1 on FDA's record

K092619 — ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKERCivco·cleared 2009-11-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.