FDAHealthSeptember 16, 2025
Surgical Theater Inc — SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 16, 2025
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.
What's affected?
- Product
- SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
- Brand
- Surgical Theater Inc
- Lot code
- UDI/DI 00863157000336
Additional details
UDI/DI 00863157000336
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 45 units.
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