Spine & Trauma 3D Navigation 1 — Class I medical device recall Z-1082-2019
Terminated recall by Brainlab AG, reported 2019-04-24, distributed nationwide. In certain occurrences, the affected navigation software application might unexpectedly display a navigated in
| Recall number | Z-1082-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Munich, N/A, Germany |
| Recall initiated | 2019-02-27 |
| Classified | 2019-04-15 |
| Reported by FDA | 2019-04-24 |
| Terminated | 2019-07-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CZ, DE, DK, EC, ES, FR, GB, GR, HK, IE, IT, JP, MY, NZ, PH, SE, TH, TW, ZA |
| Quantity | 148 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04056481140328 |
Product
Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable minimally invasive surgery.
Reason for recall
In certain occurrences, the affected navigation software application might unexpectedly display a navigated instrument in an axial, coronal/sagittal (ACS) view representation with fixed planes in the image reconstruction (the not-updated ACS view ), instead of displaying the desirable view representation Inline View , which is commonly used for navigating invasive instruments at the spine. This could lead the surgeon to be unable to determine the position of the navigated instrument. This might occur after a crash restore or after changing between different navigation workflows during the same patient treatment.
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-1082-2019. 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.