Brainlab ExacTrac Dynamic software — Class II medical device recall Z-1259-2023
Ongoing recall by Brainlab AG, reported 2023-03-22, distributed nationwide. Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow
| Recall number | Z-1259-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Munich, N/A, Germany |
| Recall initiated | 2023-02-14 |
| Classified | 2023-03-16 |
| Reported by FDA | 2023-03-22 |
| Distributed | Nationwide (US) |
| Quantity | 56 systems |
| UPC / GTIN / UDI-DI | 04056481143978 |
| Model numbers | 20910-01E, 20910-01F |
Product
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Reason for recall
Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
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-1259-2023. 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.