# FDA recall Z-0322-2026

> **Surgical Theater Inc** · Class II · device recall initiated 2025-09-16.

## Product

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

## 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.

## 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.

## Key facts

- **Recall number:** Z-0322-2026
- **Recalling firm:** Surgical Theater Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-16
- **Report date:** 2025-11-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Beachwood, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0322-2026

## Citation

> AI Analytics. FDA recall Z-0322-2026. Retrieved 2026-08-02 from https://api.ai-analytics.org/recall/Z-0322-2026. Source: US FDA. Licensed CC0.

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