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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