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Endo Surgical Navigation Advanced Platform Patient… recallZ-0323-2026 · Surgical Theater Inc · initiated Sep 16, 2025

Completed

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Surgical Theater Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Under Investigation by firm

What the company is doing

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 [email protected]. 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: [email protected]

Recall details

Recall number
Z-0323-2026
Status
Completed
Initiated by the company
Sep 16, 2025
Posted by the FDA
Oct 24, 2025
Recalling firm
Surgical Theater Inc
Quantity
19 units
Product code
LLZ
FDA submissions
K160584
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.

Product description

Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological system

Code information (models, lots, serial numbers)

UDI/DI 00863157000329

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

3 devices cleared under K160584 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 97715).

Sources and updates

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