Brainlab AG recalls iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal…

Recall date

November 19, 2014

Source

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

Recall number

Z-0956-2015

FDA classification

Class II

Brand / firm

Brainlab AG

Sold / distributed

Worldwide Distribution - USA including Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire,…

Why it was recalled

iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets.

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

What was recalled

iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.