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U.S. Department of Health and Human Services

Class 2 Device Recall Surgical Theater

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 Class 2 Device Recall Surgical Theatersee related information
Date Initiated by FirmSeptember 16, 2025
Date PostedOctober 24, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0320-2026
Recall Event ID 97715
510(K)NumberK160584 
Product Classification System, image processing, radiological - Product Code LLZ
ProductSurgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
Code Information UDI/DI 00863157000305
Recalling Firm/
Manufacturer		 Surgical Theater Inc
23645 Mercantile Rd Ste M
Beachwood OH 44122-5936
For Additional Information ContactKevin Murrock
330-472-6520
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Under Investigation by firm
ActionSurgical 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
Quantity in Commerce17 units
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LLZ
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