FDAFDA · Food and drugs·Recall number Z-0588-2015
MEVION S250, used for proton radiation therapy.
Published December 17, 2014 · Recall initiated: November 10, 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
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%.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Mevion Medical Systems, Inc.
- Distributor
- US Distribution in the state of MO
- Lot
- Serial Number: S250-0001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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