ExacTrac Dynamic — Class II medical device recall Z-1185-2021
Terminated recall by Brainlab AG, reported 2021-03-17, distributed in AR, AZ, CA, IN, NC, NJ, NY, OR. In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly be
| Recall number | Z-1185-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Munich, Germany |
| Recall initiated | 2021-03-01 |
| Classified | 2021-03-08 |
| Reported by FDA | 2021-03-17 |
| Terminated | 2023-03-20 |
| Distributed | AR, AZ, CA, IN, NC, NJ, NY, OR |
| Countries outside the US | AE, AT, AU, BE, DE, DK, ES, FR, GB, HK, IT, SK, TH, TR |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04056481142315 |
| Model numbers | 20910-06ETD |
Product
ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
Reason for recall
In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined tolerances and may allow the user to proceed to treatment despite potentially exceeding shift values.
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-1185-2021. 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.