Device product
HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.
Z-2691-2016
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 74967
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13
- Official record key
device-enforcement:Z-2691-2016
Official wording
Reason: Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position.
Code information: iGuide 2.2.0
Distribution pattern: Worldwide Distribution - US Nationwide in the states of LA, PA, WA, and the countries of: Australia, Denmark, France, India, Italy, and Japan.
Derived failure modes
-
Unknown
Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position.