Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | September 16, 2025 |
| Reported | November 05, 2025 |
| Recalling firm | Surgical Theater Inc |
| Country / region | United States OH |
Hazard
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.
Affected products
- Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
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