FDAFDA · Alimentos y medicamentos·N.º oficial Z-0814-2013
GE Healthcare, Dash Port 2 Docking Station. Product Usage: is a docking station (quick mount/dismount base) for a Dash patient monitor. The system is to monitor physiologic parameter data on adult, pediatric, and neonatal patients.
Publicado el 20 de febrero de 2013 · Inicio del retiro: 13 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
GE has become aware of multiple issues affecting the Dash 3000/4000/5000 and DashPort 2 monitor. This report of correction encompasses the DashPort 2 device, in which the DashPort 2 stops communicating with the Dash, resulting in Loss of Monitoring at the CIC. The DashPort 2 status LEDs in the back of the unit indicate Unity Network and DashPort 2 to Dash communication has stopped.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare, LLC
- Distribuidor
- Worldwide Distribution and US (nationwide) including DC and the countries of ALGERIA, ARAB EMIRATES, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, CYPRUS, CZECH REPUBLIC, DENMARK, EGYPT, FRANCE, GERMANY, INDIA, ISRAEL, ITA LY, JAPAN, JORDAN, KUWAIT, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE SLOVENIA, SOUTH KOREA, SPAIN SWEDEN SWITZERLAND, TAIWAN, TURKEY, UNITED KINGDOM.
- Lote
- Mfg Lot or Serial # SE507460028GA SE507460050GA SE507460053GA SE507460054GA SE507460055GA SE507460056GA SE507460057GA SE507460058GA SE507460059GA SE507460060GA SE507460061GA SE507460062GA SE507460063GA SE507460066GA SE507460067GA SE507480070GA SE507480071GA SE507480073GA SE507480075GA SE507480077GA SE507480078GA SE507480079GA SE507480080GA SE507480082GA SE507480083GA SE507480084GA SE507480085GA SE507480091GA SE507480098GA SE507480099GA SE507480101GA SE507480102GA SE507480105GA SE507480108GA SE507480109GA SE507480110GA SE507480115GA SE507480118GA SE507480120GA SE507480123GA SE507480124GA SE507480125GA SE507480135GA SE507480139GA SE507480148GA SE507480163GA SE507480168GA SE507480178GA SE507480185GA SE507480191GA SE507480192GA SE507480196GA SE507480197GA SE507480198GA SE507480201GA SE507480213GA SE507480217GA SE507480222GA SE507480225GA SE507480226GA SE507480230GA SE507480233GA SE507480234GA SE507480237GA SE507480245GA SE507480246GA SE507480247GA SE507480248GA SE507480250GA SE507480251GA SE507480256GA SE507480257GA SE507480258GA SE507480259GA SE507480260GA SE507480264GA SE507480268GA SE507480269GA SE507480274GA SE507480282GA SE507480289GA SE507480294GA SE507490301GA SE507490306GA SE507490308GA SE507490310GA SE507490312GA SE507490313GA SE507490314GA SE507490317GA SE507490319GA SE507490322GA SE507490323GA SE507490324GA SE507490326GA SE507490329GA SE507490331GA SE507490334GA SE507490337GA SE507490340GA SE507490341GA SE507490342GA SE507490343GA SE507490345GA SE507490385GA SE507490386GA SE507490387GA SE507490388GA SE507490389GA SE507490390GA SE507490391GA SE507490392GA SE507490393GA SE507490394GA SE507490395GA SE507490396GA SE507490397GA SE507490398GA SE507490399GA SE507490400GA SE507490401GA SE507490402GA SE507490403GA SE507490404GA SE507490405GA SE507490406GA SE507490407GA SE507490414GA SE507490419GA SE507490420GA SE507490421GA SE507490422GA SE507490423GA SE507490425GA SE507490432GA SE507490433GA SE507490435GA SE507490437GA SE507490439GA SE507490440GA SE507490446GA SE507490450GA SE507490451GA SE507490452GA SE507490453GA SE507490455GA SE507490457GA SE507490458GA SE507490459GA SE507490460GA SE507490461GA SE507490462GA SE507490463GA SE507490464GA SE507490465GA SE507490467GA SE507490468GA SE507490474GA SE507490477GA SE507490479GA SE507490480GA SE507490483GA SE507490484GA SE507490485GA SE507490486GA SE507490489GA SE507490492GA SE507490493GA SE507490494GA SE507490495GA SE507490497GA SE507490502GA SE507490503GA SE507490504GA SE507490505GA SE507490506GA SE507490507GA SE507490508GA SE507490509GA SE507490510GA SE507490511GA SE507490512GA SE507490513GA SE507490518GA SE507490519GA SE507490520GA SE507490521GA SE507490522GA SE507490523GA SE507490525GA SE507490527GA SE507490528GA SE507490529GA SE507490530GA SE507490531GA SE507490532GA SE507490533GA SE507500534GA SE507500535GA SE507500536GA SE507500537GA SE507500538GA SE507500539GA SE507500540GA SE507500541GA SE507500542GA SE507500543GA SE507500544GA SE507500545GA SE507500546GA SE507500547GA SE507500548GA SE507500549GA SE507500550GA SE507500553GA SE507500554GA SE507500555GA SE507500556GA SE507500557GA SE507500558GA SE507500559GA SE507500560GA SE507500561GA SE507500562GA SE507500563GA SE507500564GA SE507500565GA SE507500567GA SE507500568GA SE507500570GA SE507500571GA SE507500572GA SE507500573GA SE507500574GA SE507500575GA SE507500576GA SE507500577GA SE507500578GA SE507500579GA SE507500581GA SE507500582GA SE507500583GA SE507500584GA SE507500585GA SE507500586GA SE507500587GA SE507500588GA SE507500589GA SE507500591GA SE507500592GA SE507500593GA SE507500594GA SE507500596GA SE507500598GA SE507500599GA SE507500601GA SE507500602GA SE507500603GA SE507500604GA SE507500605GA SE507500606GA SE507500607GA SE507500608GA SE507500609GA SE507500610GA SE50
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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