Brainlab — Class II medical device recall Z-1469-2014
Terminated recall by Brainlab AG, reported 2014-04-23, distributed in AZ, CA, GA, IL, IN, LA, MA, MI…. The "fluoro match registration" function of the Navigation Software Spine & Trauma 3D 2.0 allows the user to i
| Recall number | Z-1469-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Feldkirchen, N/A, Germany |
| Recall initiated | 2013-11-18 |
| Classified | 2014-04-17 |
| Reported by FDA | 2014-04-23 |
| Terminated | 2017-07-17 |
| Distributed | AZ, CA, GA, IL, IN, LA, MA, MI, NC, NY, OH, PA, TN, TX, WI |
| Countries outside the US | AT, AU, BE, BR, CH, CL, CZ, DE, ES, FR, GB, IT, JP, MY, NL, NO, PH, PL, SE, SG, TH, TR, ZA |
| Quantity | 133 units |
| Reason classes | software |
| Serial numbers | 000000000038012001, 000000000060912001, 000000000189912001, 000000000224912001, 000000000235512001, 000000000282912001, 000000000313612001, 000000000319412001, 000000000351112001, 000000000356912001, 000000000367212001, 000000000433712001, 000000000482012001, 000000000502812001, 000000000645612001, 000000000731112001, 000000000837312001, 000000000898312001, 000000000956812001, 000000000998412001, 000000001012812001, 000000001105412001, 000000001231812001, 000000001353512001, 000000001355412001 and 108 more |
| Model numbers | 22264 |
Product
Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264
Reason for recall
The "fluoro match registration" function of the Navigation Software Spine & Trauma 3D 2.0 allows the user to intraoperatively match e.g., CT data sets to the current patient anatomy visible on fluoroscopic images, used by the navigation software during spinal surgeries to display the position and orientation of instruments. For this registration function in combination with a digitally integrated
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-1469-2014. 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.