FDA-Device2025-11-12Class IIPROCESSING DEFECT
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Hazard
It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for visual verification of device location within the patient s anatomy.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
1198 units
Manufactured in
1100 Campus Rd, N/A, Princeton, NJ, United States
Products
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0420-2026Want us to check the next one for you?
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