FDA-Device2025-11-05Class IIPROCESSING DEFECT
Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system
Hazard
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution in the states of MI, FL, DC, MN, CA, TX, NJ, PA, AZ, NY, KY, IN, WV and the countries of Italy, Germany, Israel, UK.
Affected count
50 units
Manufactured in
23645 Mercantile Rd Ste M, N/A, Beachwood, OH, United States
Products
Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0321-2026Want us to check the next one for you?
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