Surgical Theater Inc: Device Recall

Recall Details

Recall Number

Z-0320-2026

Classification

Class II

Product Type

Device

Recalling Firm

Surgical Theater Inc

Status

Ongoing

Date Initiated

09/16/2025

Location

Beachwood, OH, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

17 units

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.

Product Description

Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system

Distribution Pattern

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.

Other Recalls by Surgical Theater Inc

• Class II: Risk 09/16/2025
  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.
• Class II: Risk 09/16/2025
  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.
• Class II: Risk 09/16/2025
  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.
• Class II: Risk 09/16/2025
  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.
• Class II: Risk 09/16/2025
  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.

View all recalls by Surgical Theater Inc →