ExacTrac Vero is a Patient Positioning System for Radiation therapy — Class II medical device recall Z-1929-2016
Terminated recall by Brainlab AG, reported 2016-06-15, distributed in FL, NY, OH, TX. Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5
| Recall number | Z-1929-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Feldkirchen, N/A, Germany |
| Recall initiated | 2016-05-04 |
| Classified | 2016-06-08 |
| Reported by FDA | 2016-06-15 |
| Terminated | 2017-07-24 |
| Distributed | FL, NY, OH, TX |
| Countries outside the US | BE, DE, FR, IT, JP, KR |
| Quantity | 27 systems |
| Model numbers | 20892 |
Product
ExacTrac Vero is a Patient Positioning System for Radiation therapy.
Reason for recall
Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5
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-1929-2016. 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.