FDA-Device2019-07-31Class II
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.
Medical Intelligence Medizintechnik Gmbh
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.
Sold states
Worldwide Distribution - US Nationwide
Affected count
496 units
Manufactured in
Robert-bosch-str. 8, N/A, Schwabmunchen, N/A, Germany
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2082-2019Don't want to check this manually?
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