# FDA recall Z-1006-2018

> **Brainlab AG** · Class II · device recall initiated 2018-02-14.

## Product

ExacTrac versions 6.5 through 6.5 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

The usage of workflows that deviate from the recommended specifications in the User manual for ExacTrac Patient Positioning System (versions 6.0, 6.1, 6.2, 6.5) with Auxiliary Device Interface (ADI) and Varian Clinac or Varian TrueBeam, which may result in misinterpretation of beam authorization via ADI.

## Distribution

worldwide

## Key facts

- **Recall number:** Z-1006-2018
- **Recalling firm:** Brainlab AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-14
- **Report date:** 2018-03-21
- **Termination date:** 2021-05-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Munich, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1006-2018

## Citation

> AI Analytics. FDA recall Z-1006-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-1006-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*