Surgical Theater recalls orthopedic augmented reality software version BST.9.3.0 due to potential misalignment risks when specific rotational values are applied in 2D Image Fusion.
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.
Surgical Theater Inc. is recalling their Surgical Planner software version BST.9.3.0 for orthopedic augmented reality use. This version may misalign secondary image layers if large rotational values are applied during 2D Image Fusion, potentially affecting surgical accuracy.
The software anomaly can cause secondary image layers to misalign with the primary image layer when large rotational alignment values are applied in 2D Image Fusion. This may lead to inaccurate surgical planning if the misalignment goes unnoticed.
Orthopedic surgeons and medical professionals using the Surgical Planner software version BST.9.3.0 for surgical planning. Those with specific rotational alignment values in 2D Image Fusion are most at risk.
Check for the software version BST.9.3.0 labeled as 'Surgical Planner, BrainSTORM' for orthopedic augmented reality. The unique device identifier (UDI/DI) 00860003884119 is associated with this version.
Verify your Surgical Planner software version is BST.9.3.0 for orthopedic augmented reality.
The software version BST.9.3.0 for Surgical Planner, BrainSTORM orthopedic augmented reality.
Secondary image layers may misalign with the primary image layer when large rotational values are applied in 2D Image Fusion, potentially affecting surgical accuracy.
Check for the software version BST.9.3.0 labeled as 'Surgical Planner, BrainSTORM' for orthopedic augmented reality with UDI/DI 00860003884119.
We’ve drafted a message you can send Surgical Theater to request your refund or repair — edit it as you like.
Subject: Recall Z-0325-2026 — Surgical Theater Surgical Theater Hello, I own a Surgical Theater that is covered by recall Z-0325-2026 from Surgical Theater. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
