Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CIVCO VirtuTRAX Instrument Navigator Recalled by Civco Medical Instruments Inc Due to The general purpose electromagnetic sensor was incorrectly calibrated...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Civco Medical Instruments Inc directly.
Affected Products
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
Quantity: 221 kits
Why Was This Recalled?
The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.
Where Was This Sold?
This product was distributed to 6 states: CA, IN, MA, NJ, WA, WI
About Civco Medical Instruments Inc
Civco Medical Instruments Inc has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report