FDAFDA · Alimentos y medicamentos·N.º oficial Z-2085-2014
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
Publicado el 30 de julio de 2014 · Inicio del retiro: 13 de junio de 2014
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
Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may not start communicating to the monitor and loss of the PDM parameters could occur.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare, LLC
- Distribuidor
- Worldwide Distribution: US nationwide, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, REUNION, QATAR, PORTUGAL, POLAND, PHILIPPINEs, PARAGUAY, PANAMA, NORWAY, NEW ZEALAND, NETHERLANDS, MYANMAR, MOROCCO, MEXICO, MALAYSIA, LITHUANIA, LEBANON, LATVIA, JORDAN, JAPAN, JAMAICA, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, ICELAND, HUNGARY, GREECE, GIBRALTAR, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, ECUADOR, DENMARK, CZECH REPUBLIC, CYPRUS, CROATIA, CHILE, BRUNEI, BERMUDA, BELGIUM, BANGLADESH, AUSTRIA, AUSTRALIA.
- Lote
- CARESCAPE MONITOR B850: Mfg Lot or Serial # System ID PA1793340 2044032-002+940481 PA1841631 2044032-002+956091 PA1841635 2044032-002+956091 PA1841639 2044032-002+956091 PA1962678 2044032-002+950202 SED09130286GP 2042395-001+889146 SED09130290GP 2042395-001+889146 SED09130291GP 2042395-001+889146 SED09130296GP 2042395-001-884783 SED09130298GP 2042395-001+889146 SED09130302GP 2042395-001+889148 SED09130304GP 2042395-001+887796 SED09130307GP 2042395-001-885430 SED09130312GP 2042395-001+889880 SED09180333GP 2042395-001+889148 SED09180334GP 2042395-001+887796 SED09180338GP 2042395-001+889148 SED09180341GP 2042395-001+889880 SED09220344GP 2042395-001+889880 SED09220345GP 2042395-001+889880 SED09220346GP 2042395-001+889880 SED09220347GP 2042395-001+889880 SED09220348GP 2042395-001+889880 SED09220350GP 2042395-001+889880 SED09220355GP 2042395-001+889880 SED09220357GP 2042395-001+889880 SED09220358GP 2042395-001+889880 SED09220365GP 2042395-001+889880 SED09220367GP 2042395-001+889880 SED09220371GP 2042395-001+889880 SED09220372GP 2042395-001+889880 SED09220373GP 2042395-001+889880 SED09220375GP 2042395-001+889880 SED09220377GP 2042395-001+889880 SED09220378GP 2042395-001+889880 SED09220380GP 2042395-001+889880 SED09220381GP 2042395-001+889880 SED09220382GP 2042395-001+889880 SED09220383GP 2042395-001+889880 SED09230384GP 2042395-001+889880 SED09230385GP 2042395-001+889880 SED09230386GP 2042395-001+889880 SED09230388GP 2042395-001+889880 SED09230390GP 2042395-001+889880 SED09240401GP 2042395-001+889880 SED09280402GA 2042395-001+889072 SED09280403GA 2042395-001+889072 SED09280404GA 2042395-001+905096 SED09280405GA 2042395-001+893818 SED09280406GA 2042395-001+889074 SED09280407GA 2042395-001+895722 SED09280409GA 2042395-001+895148 SED09280412GA 2042395-001+895722 SED09280415GA 2042395-001+895726 SED09280417GA 2042395-001+895726 SED09280418GA 2042395-001+895148 SED09280421GA 2042395-001+895722 SED09280424GA 2042395-001+889074 SED09280425GA 2042395-001+895148 SED09280430GA 2042395-001+895148 SED09280433GA 2042395-001+895148 SED09280434GA 2042395-001+895148 SED09280435GA 2042395-001+895148 SED09280436GA 2042395-001+889074 SED09280437GA 2042395-001+895726 SED09280443GA 2042395-001+895724 SED09280444GA 2042395-001+895724 SED09280445GA 2042395-001+895724 SED09310447GA 2042395-001+902847 SED09310448GA 2042395-001+907265 SED09310450GA 2042395-001+902847 SED09310452GA 2042395-001+907265 SED09310453GA 2042395-001+907265 SED09310454GA 2042395-001+907265 SED09310456GA 2042395-001+907265 SED09310457GA 2042395-001+903825 SED09310461GA 2042395-001+907265 SED09310462GA 2042395-001+907265 SED09310467GA 2042395-001+903825 SED09310468GA 2042395-001+907265 SED09310470GA 2042395-001+907265 SED09310476GA 2042395-001+902847 SED09310477GA 2042395-001+907265 SED09310496GA 2042395-001+907265 SED09310498GA 2042395-001+907265 SED09310499GA 2042395-001+902847 SED09310501GA 2042395-001+902847 SED09310504GA 2042395-001+902847 SED09310505GA 2042395-001+902847 SED09310511GA 2042395-001+902847 SED09310513GA 2042395-001+902847 SED09310515GA 2042395-001+905096 SED09310516GA 2042395-001+902847 SED09310518GA 2042395-001+902847 SED09310520GA 2042395-001+903825 SED09310521GA 2042395-001+902847 SED09310523GA 2042395-001+905096 SED09310524GA 2042395-001+907265 SED09320527GA 2042395-001+907265 SED09320528GA 2042395-001+905096 SED09320529GA 2042395-001+907265 SED09320530GA 2042395-001+907265 SED09320531GA 2042395-001+907265 SED09320532GA 2042395-001+907265 SED09320533GA 2042395-001+907265 SED09320534GA 2042395-001+907265 SED09320535GA 2042395-001+907265 SED09320536GA 2042395-001+907265 SED09320537GA 2042395-001+907265 SED09320539GA 2042395-001+907265 SED09320540GA 2042395-001+905094 SED09320543GA 2042395-001+907265 SED09320546GA 2042395-001+907265 SED09320547GA 2042395-001+907265 SED09320548GA 2042395-001+907265 SED09320549GA 2042395-001+907265 SED09320552GA 2042
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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