Surgical Theater Inc: Medical Device Recall in 2025 - (Recall #: Z-0322-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 16, 2025

Date Posted: November 5, 2025

Recall Number: Z-0322-2026

Event ID: 97715

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.

Status: Ongoing

Product Quantity: 14 units

Code Information:

UDI/DI 00860003884102

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.

Voluntary or Mandated:

Voluntary: Firm initiated