FDAFDA · Alimentos y medicamentos·N.º oficial Z-1944-2012
MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology workflow management. Manufactured by: Impac Medical Systems 100 Mathilda Place, 5th floor Sunnyvale, Ca 94086
Publicado el 18 de julio de 2012 · Inicio del retiro: 8 de junio de 2012
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
Impac Medical became aware of a problem with the recording of the Wedge Motor Units in MOSAIQ when it resumes after a machine terminates/faults, the remaining Wedge MU was being erroneously set to zero.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Impac Medical Systems Inc
- Distribuidor
- Worldwide Distribution -- USA, including the states of VA, CT, GA, NJ and NY and the countries of Belgium, Denmark, France, and the United Kingdom.
- Lote
- Version 2.10 - all builds and version 2.20 - builds up to and including 2.20.07A7.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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