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Recall Observatory FDA recall evidence

Device product

SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system

Z-0322-2026

September 16, 2025

Class II

Product summary

Firm
Surgical Theater Inc
Event
Event 97715
Status
Ongoing
Classification
Class II
Quantity
14 units
Official record key
device-enforcement:Z-0322-2026

Official wording

Reason: 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.

Code information: UDI/DI 00860003884102

Distribution pattern: 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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software anomaly