Recall Z-0320-2026 ยท LLZ System, Image Processing, Radiological
Surgical Theater Inc
Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
| Date | Oct 24, 2025 (initiated Sep 16, 2025) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 la |
| Quantity | 17 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160584 | Surgical Navigation Advanced Platform (SNAP) Surgical Theater, LLC, Jun 28, 2016 |