Recall – Radiotherapy system software incorrectly demands verification scan

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

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020

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Location: Boston, MA, USA
Dates:  June 4-6, 2020

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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.