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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 d
Recalled July 31, 2019 · FDA recall Z-2082-2019 · Medical Intelligence Medizintechnik
Hazard
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. · FDA Class II
Units
496 units
Sold at
Worldwide Distribution - US Nationwide
Description
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.
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.
Manufacturer(s)
Medical Intelligence Medizintechnik Gmbh
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →