Skip to content
Recall Observatory FDA recall evidence

Device product

iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.

Z-1705-2016

May 12, 2016

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 74087
Status
Terminated
Classification
Class II
Quantity
20
Official record key
device-enforcement:Z-1705-2016

Official wording

Reason: 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.

Code information: Software iGUIDE 2.1 and 2.2

Distribution pattern: IL, LA, Austria, Australia, Botswana, Germany, Denmark, France, India, Japan

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.