Civco eTRAX Needle System Starter Kit recalled for incorrect needle position display
Stop using Civco eTRAX Needle System Starter Kit
Civco Medical Instruments identified a programming error in the eTRAX Needle System Starter Kit 12G (Part Number 667-149) for Aurora Trackers. This error can cause the needle tip position to display incorrectly on the user interface, potentially affecting procedure accuracy. Two units were affected and distributed to Ohio, Pennsylvania, and Washington.
- Stop using the eTRAX Needle System Starter Kit 12G (Part Number 667-149) immediately
- Check if you have lot number A228672
- Contact Civco Medical Instruments for instructions on replacement or return
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1731-2026More Civco Medical Instruments Co. Inc. recalls
- FDA-Device2026-04-08Civco eTRAX Needle System Starter Kit recalled for inaccurate needle position display
- FDA-Device2026-04-08Civco eTRAX Needle Sensor 18G recalled for incorrect position display
- FDA-Device2026-04-08Civco eTRAX Needle System Starter Kit recalled for incorrect needle tip position display
- FDA-Device2026-04-08Civco eTRAX Needle Sensor 14G recalled for incorrect needle tip positioning
- FDA-Device2026-04-08Civco eTRAX Needle System Starter Kit recalled for incorrect needle position display
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