Reported Sep 7, 2016 · Terminated
HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with…
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?
- HexaPOD evo RT System Product UsageThe intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment
- Lot codes and dates
- iGuide 2.2.0
- Amount recalled
- 13
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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