Reported Jul 8, 2020 · Terminated
Elekta Unity, Image-Guided Radiation Therapy System
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?
- Elekta Unity, Image-Guided Radiation Therapy System
- Lot codes and dates
Elekta Unity Serial numbers 600014600016600017600018600019600020600021600022600023600024600025600026600027600028600029600030600031600032600033600034600035
- Amount recalled
- 21 devices
Where it was sold
Why it was recalled
There have been reports of excessive heating in the MRL Gradient Connection Module.
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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