ExacTrac versions 6 — Class II medical device recall Z-1316-2015
Terminated recall by Brainlab AG, reported 2015-04-01. The ExacTrac 6.x Patient Positioning System may incorrectly position the patient when using the ExacTrac Cone
| Recall number | Z-1316-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Feldkirchen, Germany |
| Recall initiated | 2015-02-16 |
| Classified | 2015-03-25 |
| Reported by FDA | 2015-04-01 |
| Terminated | 2017-02-28 |
| Countries outside the US | AT, AU, CA, DE, DK, FR, GB, HK, JP, KR, RU, SG |
| Model numbers | 48320, 49971 |
Product
ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
Reason for recall
The ExacTrac 6.x Patient Positioning System may incorrectly position the patient when using the ExacTrac Cone Beam CT (CBCT) with a TrueBeam-specific optional subvolume-CBCT.
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-1316-2015. 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.