Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0319-2026 — SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system

U.S. FDA — Device Enforcement · United States · 2025-09-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0319-2026
Date of alert
2025-09-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Surgical Theater Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00863157000336
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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