Company: Brainlab AG
Date of Enforcement Report: 5/1/2019
Class II:

PRODUCT

RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected: – Cranial SRS 1.0.0 and 1.5.0 – Spine SRS 1.0.0 and 1.5.0 – Multiple Brain Mets SRS 1.5.0 – RT QA 1.0.0 and 1.5.0 Product Usage: The RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck and extracranial lesions.

Recall Number: Z-1205-2019

REASON

There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements software (for affected versions) under specific circumstances when using the Pencil Beam algorithm on the GPU (graphics card), as is the default system setting.

RECALLING FIRM/MANUFACTURER

Brainlab AG on 3/11/2019. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
US – 164 units; Outside the US – 333

DISTRIBUTION

US Nationwide and International