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Surgical Theater Recalls
7 recalls on record · November 5, 2025 to November 5, 2025 · Medical Devices
November 5, 2025Medical DevicesFDA
Surgical Theater Inc recalls Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
Hazard: 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.
November 5, 2025Medical DevicesFDA
Surgical Theater Inc recalls SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic a
Hazard: 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.
November 5, 2025Medical DevicesFDA
Surgical Theater Inc recalls Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processin
Hazard: 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.
November 5, 2025Medical DevicesFDA
Surgical Theater Inc recalls SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging proc
Hazard: 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.
November 5, 2025Medical DevicesFDA
Surgical Theater Inc recalls Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radi
Hazard: 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.
November 5, 2025Medical DevicesFDA
Surgical Theater Inc recalls Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
Hazard: 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.
November 5, 2025Medical DevicesFDA
Surgical Theater Inc recalls SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
Hazard: 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.