FDA Device recall Z-1006-2018
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 medic…
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of 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 medic… by Brainlab Ag, citing 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 Dev….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1006-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-14 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Brainlab Ag |
| Distribution | n/a |
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
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.
Identifiers
| code_info | UDI: GTIN for ExacTrac 6.0 and 6.1 is not applicable GTIN for ExacTrac 6.2 is: 04056481000264 GTIN for ExacTrac 6.…UDI: GTIN for ExacTrac 6.0 and 6.1 is not applicable GTIN for ExacTrac 6.2 is: 04056481000264 GTIN for ExacTrac 6.5 is: 04056481138400 License No. Description 20833 EXACTRAC 6.0 IR POSITIONING SOFTWARE 20834 EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE 20835 EXACTRAC 6.0 IR MONITORING SOFTWARE 20853 EXACTRAC 6.0 X-RAY LIMITED SOFTWARE 20871 EXACTRAC 6.1 X-RAY POSITIONING SOFTWARE 20872 EXACTRAC 6.1 IR POSITIONING SOFTWARE 20873 EXACTRAC 6.1 X-RAY MONITORING SOFTWARE 20874 EXACTRAC 6.1 X-RAY LIMITED SOFTWARE 20881 EXACTRAC 6.2 X-RAY POSITIONING SOFTWARE 20884 EXACTRAC 6.2 X-RAY LIMITED SOFTWARE 20833A EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833C EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833D EXACTRAC 6.0 IR POSITIONING SOFTWARE 20833E EXACTRAC 6.0 IR POSITIONING SOFTWARE 20834A EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE 20834B EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE 20834C EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE 20834D EXACTRAC 6 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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FDA Device · Class II · 2023-03-22 · Brainlab Ag - ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST
FDA Device · Class II · 2022-03-16 · Brainlab Ag - ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at…
FDA Device · Class II · 2021-06-16 · Brainlab Ag
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1006-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.