SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (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.
Publicado el 4 de septiembre de 2013 · Inicio del retiro: 3 de abril de 2013
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 Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH, PDM, and/or Tram Module. ECG and Respiration signal noise caused by DASH, PDM, and/or Tram ECG cable connector movement may result in reduced ECG, Respiration and arrhythmia detection performance.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare, LLC
- Distribuidor
- Worldwide Distribution - USA Nationwide including DC and PR except ND and the countries of: ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOSNIA-HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, CHANA, GREECE, HONDURAS, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, MALAYSIA, MEXICO, MOROCCO, NEPAL, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, PANAMA, PARAGUAY, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAK IA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNSIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, BOLIVIA, HONG KONG, JAMAICA, PHILIPPINES, SOUTH KOREA, TRINIDAD TOBAGO, URUGUAY, VENEZUELA.
- Lote
- Mfg Lot or Serial # SA310290653GA SA310290655GA SA310290657GA SA310290659GA SA310290661GA SA310290748GA SA310290749GA SA310290750GA SA310290754GA SA310290755GA SA310290756GA SA310290757GA SA310290758GA SA310290759GA SA310361647GA SA310361877GA SA310372108GA SA310393017GA SA310393052GA SA310382648GA SA310382626GA SA310382631GA SA310382729GA SA310382761GA SA310393037GA SA310393054GA SA310393071GA SA310393073GA SA310351531GA SA310361792GA SA310361798GA SA310361801GA SA310361803GA SA310361804GA SA310361805GA SA310361807GA SA310361808GA SA310361815GA SA310361820GA SA310361838GA SA310361840GA SA310361841GA SA310393150GA SA310393155GA SA310393162GA SA310393165GA SA310393166GA SA310393167GA SA310393170GA SA310393171GA SA310393173GA SA310393175GA SA310321055GA SA310321062GA SA310361949GA SA310382418GA SA310382450GA SA310382499GA SA310382513GA SA310382608GA SA310382647GA SA310382649GA SA310382663GA SA310393156GA SA310393158GA SA310393164GA SA310393169GA SA310393177GA SA310259944GA SA310331337GA SA310331342GA SA310331343GA SA310331345GA SA310331349GA SA310331351GA SA310341373GA SA310341376GA SA310341387GA SA310341388GA SA310341399GA SA310341400GA SA310341401GA SA310341402GA SA310341403GA SA310341406GA SA310382386GA SA310382391GA SA310382472GA SA310382476GA SA310382477GA SA310382479GA SA310382484GA SA310382494GA SA310382618GA SA310382619GA SA310382634GA SA310382636GA SA310382645GA SA310382378GA SA310382449GA SA310382511GA SA310382606GA SA310382607GA SA310382610GA SA310382612GA SA310382613GA SA310382615GA SA310382616GA SA310382642GA SA310382652GA SA310382656GA SA310382664GA SA310423572GA SA310423573GA SA310290745GA SA310290753GA SA310413471GA SA310413476GA SA310423587GA SA310423607GA SA310413493GA SA310413498GA SA310413500GA SA310413507GA SA310413514GA SA310413524GA SA310413535GA SA310423604GA SA310423606GA SA310423611GA SA310423617GA SA310423619GA SA310423621GA SA310423626GA SA310423640GA SA310423649GA SA310423650GA SA310423730GA SA310423821GA SA310423825GA SA310423836GA SA310423838GA SA310423842GA SA310423864GA SA310423929GA SA310423935GA SA310423943GA SA310423959GA SA310423962GA SA310424000GA SA310424001GA SA310424017GA SA310413491GA SA310413499GA SA310413509GA SA310413511GA SA310413538GA SA310423613GA SA310423614GA SA310423618GA SA310423622GA SA310423628GA SA310423637GA SA310423639GA SA310423663GA SA310423709GA SA310423933GA SA310423937GA SA310423946GA SA310423950GA SA310423953GA SA310423956GA SA310423957GA SA310423960GA SA310423961GA SA310423967GA SA310423971GA SA310424002GA SA310424003GA SA310424004GA SA310424006GA SA310424008GA SA310424025GA SA310424027GAMKE SA310424033GA SA310424034GAMKE SA310424039GA SA310424046GA SA310434199GAMKE SA310434200GA SA310434204GAMKE SA310434205GA SA310434207GAMKE SA310434208GA SA310434210GA SA310434211GAMKE SA310434212GA SA310434213GA SA310434227GAMKE SA310434238GA SA310444247GAMKE SA310444253GAMKE SA310372179GA SA310382540GA SA310382541GA SA310382542GA SA310382544GA SA310382550GA SA310382553GA SA310382554GA SA310382557GA SA310382558GA SA310382562GA SA310382563GA SA310382575GA SA310382580GA SA310382593GA SA310382599GA SA310382602GA SA310382604GA SA310382693GA SA310403363GA SA310403364GA SA310403372GA SA310403433GA SA310423758GA SA310423793GA SA310423896GA SA310423914GA SA310423917GA SA310423919GA SA310423979GA SA310423994GA SA310434070GA SA310423777GA SA310423779GA SA310423787GA SA310423819GA SA310423871GA SA310444296GA SA310310864GA SA310382832GA SA310392903GA SA310392904GA SA310392943GA SA310392946GA SA310392997GA SA310392999GA SA310393006GA SA310393007GA SA310393008GA SA310393010GA SA310393011GA SA310393012GA SA310393015GA SA310393023GA SA310393026GA SA310393029GA SA310393035GA SA310393036GA SA310393048GA SA310393059GA SA310393061GA SA31039
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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