Brainlab AG recalls RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Lin…

Recall date

November 5, 2015

Source

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

Recall number

Z-0648-2016

FDA classification

Class II

Brand / firm

Brainlab AG

Sold / distributed

Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Mexico, Portugal, South Korea, Spain, Switzerland, Turkey and the United Kingdom.

Why it was recalled

Large objects with fine resolution are potentially displayed cropped when imported into Adaptive Hybrid Surgery Analysis version 1.0.0

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

What was recalled

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. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms