FDAHealthSeptember 16, 2025
Surgical Theater Inc — Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
⚠️ 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, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
- Brand
- Surgical Theater Inc
- Lot code
- UDI/DI 00860003884119
Additional details
UDI/DI 00860003884119
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3 units.
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