Reported Jun 1, 2016 · Terminated
iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
Elekta, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Elekta, Inc. · 400 Perimeter Center Ter NE Ste 50 · Atlanta, GA · 30346-1227
Is this the product you have?
- iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
- Lot codes and dates
- Software iGUIDE 2.1 and 2.2
- Amount recalled
- 20
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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