SuRgical Planner — Class II medical device recall Z-0319-2026
Terminated recall by Surgical Theater Inc, reported 2025-11-05, distributed nationwide. A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image F
| Recall number | Z-0319-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Surgical Theater Inc, Beachwood, OH, United States |
| Recall initiated | 2025-09-16 |
| Classified | 2025-10-24 |
| Reported by FDA | 2025-11-05 |
| Terminated | 2026-08-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, GB, IL, IT |
| Quantity | 45 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00863157000336 |
Product
SuRgical Planner (SRP), software version SRP.7.12.0, 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0319-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.