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Recall Observatory FDA recall evidence

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

August 18, 2016

Class II

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

    reason.no_named_rule · v1.0.0

    Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position.