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

Medical DevicesSource: FDA (device) · Date: 2025-11-05

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Surgical Theater Inc
Product
SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system
Reason / 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.
Classification
Class II
Status
Terminated
Distribution / sold at
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.
Recall initiated
2025-09-16
Code info
UDI/DI 00860003884102
Product quantity
14 units
Voluntary mandated
Voluntary: Firm initiated
City
Beachwood
State
OH
Country
United States
Event id
97715
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