ExacTrac 6 — Class II medical device recall Z-1582-2015
Terminated recall by Brainlab AG, reported 2015-05-13, distributed nationwide. ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac Con
| Recall number | Z-1582-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Feldkirchen, N/A, Germany |
| Recall initiated | 2015-03-06 |
| Classified | 2015-05-06 |
| Reported by FDA | 2015-05-13 |
| Terminated | 2017-04-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CH, CN, DE, DK, FR, HK, JP, KR, NL, QA |
| Model numbers | 49971 |
Product
ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
Reason for recall
ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac Cone Beam CT (CBCT) with a CBCT acquired at a couch angle other than 0.0 degrees.
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-1582-2015. 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.