Company: Medical Intelligence Medizintechnik Gmbh
Date of Enforcement Report: 7/31/2019
Class II

PRODUCT

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.

Recall Number: Z-2082-2019

REASON

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.

RECALLING FIRM/MANUFACTURER

Medical Intelligence Medizintechnik Gmbh on 7/18/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
496 units

DISTRIBUTION

US Nationwide and Worldwide