FDAFDA · Food and drugs·Recall number Z-1271-2014
MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Published April 2, 2014 · Recall initiated: March 5, 2014
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
Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Mevion Medical Systems, Inc.
- Distributor
- USA Nationwide Distribution in the state of MO
- Lot
- S250-0001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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