Brainlab AG recalls ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treat…

Recall date

February 14, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1006-2018

FDA classification

Class II

Brand / firm

Brainlab AG

Sold / distributed

worldwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.