Surgical Planner recall: Software Issue
Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
Why was Surgical Planner 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 00860003884119
- Product
- Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
- Recalling firm
- Surgical Theater Inc
- Quantity
- 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.
- Recall date
- November 5, 2025
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)