ExacTrac is intended to be used to place patients at an accurately… — Class II medical device recall Z-2146-2014
Terminated recall by Brainlab AG, reported 2014-08-13, distributed in CA, CT, IL. When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditi
| Recall number | Z-2146-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Feldkirchen, N/A, Germany |
| Recall initiated | 2014-06-24 |
| Classified | 2014-08-04 |
| Reported by FDA | 2014-08-13 |
| Terminated | 2017-04-24 |
| Distributed | CA, CT, IL |
| Countries outside the US | DE, FR, JP, NL, RU, SI |
| Quantity | 15 systems |
Product
ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.
Reason for recall
When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green "OK" icon. If this anomaly occurs and is not detected by the user, the radiation treatment dose at the linear accelerator may be delivered to the unintended target position.
Machine access
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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.