ExacTrac 5 — Class II medical device recall Z-1707-2014
Terminated recall by Brainlab AG, reported 2014-06-11, distributed nationwide. When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS),
| Recall number | Z-1707-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Feldkirchen, Germany |
| Recall initiated | 2014-04-15 |
| Classified | 2014-06-03 |
| Reported by FDA | 2014-06-11 |
| Terminated | 2017-04-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, FI, IN, JP, NL, OM, RU, TW |
| Quantity | 40 systems |
Product
ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
Reason for recall
When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient.
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-1707-2014. 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.