Reported Jun 25, 2014 · Terminated
iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the…
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 · Atlanta, GA · 30346-1227
Is this the product you have?
- iGUIDE System Product UsageThe intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment
- Lot codes and dates
Software Versions 2.0.02.0.1 and 2.0.2
- Amount recalled
- 224
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
A bug in the software prevents the iGUIDE software from logging off.
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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