Endo SNAPRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

3 other recalls cover devices cleared under the same FDA submission (K160584); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Sep 16, 2025Completed

   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.

   Z-0323-2026 · Root cause: Under Investigation by firm · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160584. One submission often covers many models, so check the product and lot details in each record.

• Z-0321-2026 · Sep 16, 2025 · Completed
  Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system
• Z-0320-2026 · Sep 16, 2025 · Completed
  Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
• Z-0322-2026 · Sep 16, 2025 · Completed
  SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system