Reported Jun 25, 2014 · Terminated
Synergy XVI Intended for radiation therapy treatment.
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?
- Synergy XVI Intended for radiation therapy treatment.
- Lot codes and dates
XVI R4.0 to R4.2.1R4.5.0R4.5.1and R5.0.0 to R5.0.1
- Amount recalled
- 380 US
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
XVI can incorrectly calculate the target position of the treatment table.
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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