Home / Recalls / Medical Devices
Elekta, Inc. recalls iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
Recalled June 1, 2016 · FDA recall Z-1705-2016 · Elekta
Hazard
If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data. · FDA Class II
Units
20
Sold at
IL, LA, Austria, Australia, Botswana, Germany, Denmark, France, India, Japan
Description
If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data.
Product
iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
Manufacturer(s)
Elekta, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →