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.
Publicado el 22 de agosto de 2018 · Inicio del retiro: 29 de junio de 2018
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- Mevion Medical Systems, Inc.
- Distribuidor
- US Nationwide Distribution in the states of DC, FL, MO, NJ, OH, and OK.
- Lote
- S250-0001 through S250-0006 and S250i-0007
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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