Recall Z-0320-2026— Surgical Theater Inc
Class II · Ongoing
Class II FDA medical device recall by Surgical Theater Inc, initiated 2025-09-16. It names one FDA 510(k) clearance: K160584. Product: Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system. 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..
- Recalling firm
- Surgical Theater Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-09-16
- Firm location
- Beachwood, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.