Recall Z-1006-2018— Brainlab AG

Name: FDA recall Z-1006-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-14

Class II · Terminated

Class II FDA medical device recall by Brainlab AG, initiated 2018-02-14, terminated 2021-05-17. It names one FDA 510(k) clearance: K120789. 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..

Recalling firm: Brainlab AG
Classification: Class II
Status: Terminated
Initiated: 2018-02-14
Terminated: 2021-05-17
Firm location: Munich, Germany

510(k) clearances named in this recall

1 on FDA's record

K120789 — EXACTRAC X-RAY X-RAYBrainlab AG·cleared 2012-08-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.