FDA Medical devices recall ·
SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR… recall
- Recall number
- Z-0322-2026
- Date
- (initiated September 16, 2025)
- Company / brand
- Surgical Theater Inc
23645 Mercantile Rd Ste M, Beachwood, OH, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Terminated
- Units affected
- 14 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 00860003884102
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.
States: Arizona California District of Columbia Florida Indiana Kentucky Michigan Minnesota New Jersey New York Pennsylvania Texas West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0322-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.