FDAFDA · Alimentos y medicamentos·N.º oficial Z-1733-2014
Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: SMN 10706557 SKIT Air Compressor Assy, used on the Dimension Vista 500 and Dimension Vista 1500 systems. Siemens Healthcare Diagnostics Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensory technology for clinical use.
Publicado el 18 de junio de 2014 · Inicio del retiro: 14 de abril 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
A small number of Vista Air Compressors were miswired, which if installed and powered up, could cause a fire, or become an electrical shock hazard.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Siemens Healthcare Diagnostics, Inc.
- Distribuidor
- Worldwide Distribution: US Distribution to states of: IL, OH and TN; and country of: Italy.
- Lote
- Product Siemens Material Number (SMN) Dimension Vista 500 Domestic: 10284473 International: 10488224 Dimension Vista 1500 Domestic: 10444801 International: 10444802 Serial #s: 0913900306 0913900355
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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