FDAFDA · Food and drugs·Recall number Z-0409-2017
MEVION S250 Product Usage: Proton Radiation Therapy
Published November 23, 2016 · Recall initiated: October 31, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Completing Setup Without Program Move Complete Can Cause An Isocenter Error
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mevion Medical Systems, Inc.
- Distributor
- US Nationwide in the states of FL, MO, NJ and OK
- Lot
- Serial NUmbers: S250-0001 through S250-0006
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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