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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0202-2018

CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software The PDM is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes EGG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes.

Publicado el 13 de diciembre de 2017 · Inicio del retiro: 13 de julio de 2017

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

Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
GE Medical Systems Information Technologies, Inc.
Distribuidor
Worldwide Distribution - US including NY, WI; Foreign: Australia, France, Germany.
Lote
Model No. 2042084-001. Serial No. SA314096842GA, SA314212130GA, SA313430730GA, SA313430743GA, SA313430731GA, SA313430735GA, SA313430771GA, SA313430795GA, SA313430801GA, SA313430806GA, SA313430813GA, SA313441307GA, SA313441311GA, SA313441399GA, SA313441414GA, SA313441474GA, SA314086697GA, SA313272250GA, SA313378480GA, SA313419589GA, SA313430691GA, SA313430697GA, SA313430700GA, SA313430705GA, SA313430706GA, SA313430711GA, SA313430713GA, SA313430715GA, SA313430723GA, SA313430724GA, SA313430751GA, SA313430752GA, SA313430753GA, SA313430755GA, SA313430757GA, SA313430759GA, SA313430761GA, SA313430762GA, SA313430763GA, SA313430764GA, SA313430766GA, SA313430767GA, SA313430777GA, SA313430779GA, SA313430780GA, SA313430781GA, SA313430783GA, SA313430784GA, SA313430789GA, SA313430790GA, SA313430792GA, SA313430793GA, SA313430794GA, SA313430796GA, SA313430797GA, SA313430798GA, SA313430799GA, SA313430802GA, SA313430804GA, SA313430805GA, SA313430807GA, SA313430808GA, SA313430809GA, SA313430812GA,SA313430815GA, SA313430819GA, SA313430822GA, SA313430823GA, SA313430824GA, SA313430825GA, SA313430827GA, SA313430828GA, SA313430875GA, SA313430907GA, SA313430915GA, SA313430916GA, SA313431027GA, SA313431034GA, SA313431040GA, SA313431043GA, SA313431045GA, SA313431047GA, SA313431048GA, SA313431062GA, SA313431063GA, SA313431064GA, SA313431065GA, SA313431066GA, SA313431067GA, SA313431069GA, SA313431073GA, SA313431074GA, SA313431079GA, SA313431081GA, SA313431082GA, SA313431083GA, SA313431089GA, SA313431091GA, SA313431098GA, SA313431099GA, SA313431104GA, SA313431158GA, SA313441304GA, SA313441305GA, SA313441315GA, SA313441334GA, SA313441362GA, SA313441363GA, SA313441367GA, SA313441369GA, SA313441370GA, SA313441372GA, SA313441374GA, SA313441377GA, SA313441382GA, SA313441391GA, SA313441417GA, SA313441438GA, SA313441440GA, SA313441460GA, SA313441461GA, SA313441462GA, SA313441464GA, SA313441465GA, SA313441471GA, SA313441476GA, SA313441478GA, SA313441621GA, SA313441622GA, SA313441623GA, SA313441684GA, SA313441686GA, SA313441687GA, SA314065742GA, SA314065752GA, SA314065754GA, SA314065756GA, SA314065757GA, SA314065759GA, SA314065760GA, SA314065763GA, SA314065765GA, SA314065766GA, SA314065767GA, SA314065768GA, SA314065785GA, SA314065788GA, SA314065791GA, SA314065793GA, SA314075804GA, SA314075806GA, SA314075807GA, SA314075808GA, SA314075809GA, SA314075810GA, SA314075812GA, SA314075814GA, SA314075823GA, SA314075825GA, SA314075826GA, SA314075827GA, SA314075828GA, SA314075829GA, SA314075830GA, SA314075839GA, SA314075850GA, SA314075853GA, SA314075855GA, SA314075857GA, SA314075858GA, SA314075859GA, SA314075860GA, SA314075861GA, SA314075862GA, SA314075863GA, SA314075864GA, SA314086544GA, SA314086555GA, SA314086559GA, SA314086566GA, SA314086628GA, SA314086651GA, SA314086661GA, SA314086702GA, SA314086716GA, SA314096753GA, SA314096756GA, SA314096757GA, SA314096760GA, SA314096762GA, SA314096764GA, SA314096765GA, SA314096775GA, SA314096782GA, SA314096784GA, SA314096785GA, SA314096790GA, SA314096794GA, SA314096804GA, SA314096808GA, SA314096809GA, SA314096810GA, SA314096814GA, SA314096817GA, SA314096818GA, SA314096819GA, SA314096821GA, SA314096822GA, SA314096823GA, SA314096825GA, SA314096828GA, SA314096829GA, SA314096837GA, SA314096838GA, SA314096839GA, SA314096840GA, SA314096843GA, SA314096852GA, SA314096853GA, SA314096854GA, SA314096855GA, SA314096868GA, SA314096870GA, SA314096933GA, SA314096937GA, SA314096938GA, SA314096939GA, SA314096942GA, SA314096944GA, SA314096946GA, SA314096947GA, SA314096948GA, SA314096949GA, SA314096951GA, SA314096952GA, SA314096957GA, SA314096958GA, SA314096960GA, SA314096962GA, SA314096999GA, SA314097025GA, SA314097071GA, SA314097080GA, SA314097086GA, SA314097152GA, SA314097159GA, SA314097161GA, SA314107694GA, SA314107701GA, SA314107703GA, SA314108152GA, SA314149726GA, SA314159806GA, SA314160061GA, SA314160065GA, SA314160074GA, SA314160079GA, SA314160082GA, SA314160088GA, SA314160098GA, SA314160099GA, SA314160105GA, SA314170129GA, SA314170133GA,
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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