Reported Jun 5, 2013 · Terminated
Integrity 3.0 Product Usage: The Agility multileaf collimator is indicated for use when additional flexibility is…
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?
- Integrity 3.0
- Product UsageThe Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed
- Lot codes and dates
325134325254325082325159325268325237325331325267325236325314325127325261325286325077325269325129325296325273325139325201325137325184325161325076325086325112325081325083325099325110325271
- Amount recalled
- 31
Where it was sold
Why it was recalled
Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0.
This product could cause temporary or reversible health problems — stop using it.
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