Reported Sep 13, 2017 · Terminated
MOSAIQ Medical Charged-Particle 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?
- MOSAIQ Medical Charged-Particle Radiation Therapy System
- Lot codes and dates
- All software builds.
- Amount recalled
- 2,461
Where it was sold
Why it was recalled
The table shift in the vertical direction was inverted during the use of CMA (Couch Move Assistant). Therapy may be directed to an incorrect area.
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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