Reported Dec 17, 2014 · Terminated
MEVION S250, used for proton radiation therapy.
Mevion Medical Systems, 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: Mevion Medical Systems, Inc. · 300 Foster St · Littleton, MA · 01460-2017
Is this the product you have?
- MEVION S250, used for proton radiation therapy.
- Lot codes and dates
- Serial NumberS250-0001
- Amount recalled
- 1
Where it was sold
Why it was recalled
Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more than 5%.
This product could cause temporary or reversible health problems — stop using it.
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