MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.
Published August 22, 2018 · Recall initiated: June 29, 2018
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
QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QFix Couch Tops with non-QFix devices in clinical use. The kVue Oen Touch latch consists of a precision latch mechanism that can be damaged when used with incompatible (third-party) accessories. This can create unsafe conditions for use and may compromise the subsequent use of any kVue inserts, whether authorized or not. Use of unauthorized or unvalidated inserts may lead to an incorrect patient treatment or physical injury.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Mevion Medical Systems, Inc.
- Distributor
- US Nationwide Distribution in the states of DC, FL, MO, NJ, OH, and OK.
- Lot
- S250-0001 through S250-0006 and S250i-0007
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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