Medical Intelligence Medizintechnik Gmbh recalls IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device…

Recall date

July 18, 2019

Source

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

Recall number

Z-2082-2019

FDA classification

Class II

Brand / firm

Medical Intelligence Medizintechnik Gmbh

Sold / distributed

Worldwide Distribution - US Nationwide

Why it was recalled

Sometimes, although the HexaPOD has reached the target position, the Constant Correlation Check (CCC) can be too sensitive and iGUIDE may incorrectly demand a verification scan.

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, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.