Class II

Medical Device Recall: Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system

Surgical Theater Inc · September 16, 2025

Reason for Recall

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.

Distribution

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.

States Affected

NATIONWIDE

Quantity Affected

17 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0320-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Surgical Theater Inc Medical Device Recall: Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system | SafeCheck