Reported Mar 5, 2014 · Terminated
DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose…
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?
- DMLC IV-ERGO Product UsageIntended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible
- Lot codes and dates
- Identifier
116001116012116044116055116014116052116023116056116053116043116047116051116122116063116068116013116046
- Identifier
- Amount recalled
- 35 units
Where it was sold
Why it was recalled
It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems
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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