Reported Nov 23, 2016 · Terminated
MEVION S250 Product Usage: Proton Radiation Therapy System
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 Street · Littleton, MA · 01460-2017
Is this the product you have?
- MEVION S250 Product UsageProton Radiation Therapy System
- Lot codes and dates
- Serial NumbersS250-0001 through S250-0006
- Amount recalled
- 6 units
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
Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the distance of the structure from isocenter
This product could cause temporary or reversible health problems — stop using it.
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