SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
FDA Recall #Z-0319-2026 — Class II — September 16, 2025
Product Description
SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
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.
Recalling Firm
Surgical Theater Inc — Beachwood, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
45 units
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.
Code Information
UDI/DI 00863157000336
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated