VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Publicado el 24 de septiembre de 2014 · Inicio del retiro: 5 de julio de 2014
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
Software Anomaly: If a user changes the calendar setting from Workday to Holiday or vice versa, that would erroneously change the status of treatment/fractions, which are completed and to become Treated (completed) status on the exact day when such change is made, to Untreated status. Furthermore, such treatment would be cloned and mistakenly added to the schedule as Untreated treatment
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
- Distribuidor
- Distributed in the states of NY, FL, and TX.
- Lote
- Software Version 3.0.0 and after. Serial Numbers 201902, 203901, and 203919
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Japan
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