Surgical Theater Inc recalls Surgical Planner

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 Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality

Surgical Theater issued an URGENT: Medical Device Software correction notice dated September 17, 2025 to its consignees on 09/22/2025 via email. The notice explained the issue, risk to health, and provided the following: Customers can continue to use the software version(s) noted above until a software patch is made available by Surgical Theater. Until the software patch is installed, please follow these steps: 1. Read and share this notice with all relevant staff. 2. Continue to use the 3D Fusion functions to review the fusion results for all case files to verify alignment of secondary layer(s) to primary layer and to adjust fusion as necessary, and 3. Acknowledge your receipt of this notification by completing and returning the included acknowledgement form via email to quality@surgicaltheater.com. A software patch is currently undergoing verification and should be available in the next 10 days. Surgical Theater has revised the 2D Image Fusion function to ensure the x, y and z axis rotation values are consistently applied when generating the aligned Axial, Sagittal and Coronal images. In addition, the rotate left/right buttons in all three planes were modified so the volume rotation stays consistent with the respective plane orientation. A Surgical Theater representative will contact your facility to schedule installation once the patch is available. For questions regarding this notification contact: Kevin Murrock, Sr. Director of Quality & Regulatory, Tel. 330-472-6520 (Monday through Friday, 9:00 AM to 5:00 PM, Eastern Time), email: kmurrock@surgicaltheater.com

• FDA enforcement recordOfficial FDA database entry for Z-0325-2026
• FDA 510(k) clearance · K201465The device's official FDA premarket clearance record
• FDA device classification · LLZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.2050The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Surgical Theater IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.