Beachwood, OH, United States
Surgical Theater Inc recalls
1 recall recorded since 2018, most recently on 16 September 2025. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 16 September 2025
- Terminated
- 3 August 2026
- 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.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0319-2026, Z-0325-2026, Z-0323-2026, Z-0324-2026, Z-0320-2026, Z-0321-2026, Z-0322-2026
- SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
- Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
- Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological system
- SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality
- Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
- Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system
- SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.