Elekta, Inc. recalls iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.

Recall date

May 12, 2016

Source

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

Recall number

Z-1705-2016

FDA classification

Class II

Brand / firm

Elekta, Inc.

Sold / distributed

IL, LA, Austria, Australia, Botswana, Germany, Denmark, France, India, Japan

Why it was recalled

If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data.

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

What was recalled

iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.