[pending] Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
Pending LLM rewrite. Source: FDA_DEVICE Z-0325-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
- Manufacturer
- Surgical Theater Inc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI/DI 00860003884119
Distribution
Distributed nationwide across the United States.
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