FDAFDA · Alimentos y medicamentos·N.º oficial Z-0630-2013
DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.
Publicado el 9 de enero de 2013 · Inicio del retiro: 12 de mayo de 2011
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
There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Mindray DS USA, Inc. d.b.a. Mindray North America
- Distribuidor
- Nationwide Distribution including OH and GA
- Lote
- 510 K K080192 P/N 300BF-PA200002
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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