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Surgical Theater Inc FDA Recalls
7 recalls on file across devices, 0 of them Class I and 0 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological systemClass IISep 16, 2025A software anomaly, under specific conditions when large rot |
| SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging procClass IISep 16, 2025A software anomaly, under specific conditions when large rot |
| SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic aClass IISep 16, 2025A software anomaly, under specific conditions when large rot |
| Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented realityClass IISep 16, 2025A software anomaly, under specific conditions when large rot |
| Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological systemClass IISep 16, 2025A software anomaly, under specific conditions when large rot |
| Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processinClass IISep 16, 2025A software anomaly, under specific conditions when large rot |
| Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiClass IISep 16, 2025A software anomaly, under specific conditions when large rot |