Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
Reported: November 5, 2025 Initiated: September 16, 2025 #Z-0325-2026
Product Description
Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
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.
Details
- Recalling Firm
- Surgical Theater Inc
- Units Affected
- 3 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.
- Location
- Beachwood, OH
Frequently Asked Questions
What product was recalled? ▼
Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality. Recalled by Surgical Theater Inc. Units affected: 3 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 5, 2025. Severity: Moderate. Recall number: Z-0325-2026.
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