FDA Device recall Z-0322-2026
SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological…
- FDA Device
- Class II
- terminated
- Published 2025-11-05
On 2025-11-05 the FDA classified a Class II recall of SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological… by Surgical Theater, citing 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 th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0322-2026 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2025-09-16 |
| Published | 2025-11-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Surgical Theater |
| Distribution | US |
Product
SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, 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.
Identifiers
| code_info | UDI/DI 00860003884102 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0322-2026%22
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