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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2703-2017

Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1

Publicado el 19 de julio de 2017 · Inicio del retiro: 2 de mayo 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

Carestation 620, 650 and 650c has Potential for Elevated FiCO2 and Unexpected System Malfunction

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
GE Healthcare, LLC
Distribuidor
US Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL GA, ID,IL, IN, KY, LA, , MA, MD, MI, MO, MS, MT, MN, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, VA, WA, WI, and UT. OUS: Algeria Argentina Australia Austria Belgium Bolivia Bosnia and Herzegovina Brazil Bulgaria Cambodia Canada Chile Colombia Costa Rica Cote d'Ivoire Croatia Czech Republic Ecuador Egypt El Salvador Estonia Finland France Germany Greece Honduras Hong Kong Hungary India Indonesia Iraq Ireland Israel Italy Japan Jordan Kenya Korea (Republic Of) Kuwait Latvia Lebanon Lithuania Malaysia Maldives Malta Mauritius Mexico Moldova Morocco Myanmar Netherlands New Zealand Nigeria Norway Oman Pakistan Paraguay Peru Philippines Poland Portugal Romania Russia Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Tanzania Thailand Turkey United Arab Emirates United Kingdom Uruguay Vietnam Zimbabwe
Lote
Carestation 620 A1: SM616460036MA SM616460037MA SM616400001MA SM616250007MA SM616340023MA SM616460048MA SM616460049MA SM616460022MA SM616250005MA SM616400004MA SM616400005MA SM617110011MA SM617110012MA SM617110013MA SM617110014MA SM616430024MA SM616200020MA SM616200019MA SM616200021MA SM616200022MA SM616200023MA SM616200024MA SM617010108MA SM616270021MA SM616270022MA SM617020019MA SM617020020MA SM617020021MA SM616460047MA SM616340001MA SM616340002MA SM616340039MA SM616340025MA SM616460052MA SM616460053MA SM616460054MA SM616460055MA SM616460056MA SM616460057MA SM616250006MA SM616460035MA SM617010114MA SM617010115MA SM617010116MA SM617010117MA SM617010118MA SM616340027MA SM616410061MA SM616340018MA SM616340019MA SM616340020MA SM616460030MA SM616460028MA SM616460029MA SM616410043MA SM617020010MA SM617020011MA SM617020012MA SM617020013MA SM617020014MA SM617020015MA SM617020016MA SM617020017MA SM617020018MA SM617060084MA SM617100056MA SM617100057MA SM616400016MA SM616400017MA SM616170021MA SM616170022MA SM616200012MA SM616340028MA SM616340029MA SM616340030MA SM617100058MA SM616340021MA SM616430034MA SM616430035MA SM617100157MA SM616250001MA SM616250002MA SM616250003MA SM616250004MA SM617100019MA SM617100020MA SM617100021MA SM617100022MA SM617100023MA SM617100024MA SM617100025MA SM617020026MA SM616100020MA SM616100021MA SM616100022MA SM616100023MA SM616100024MA SM616200013MA SM616200016MA SM616200014MA SM616200015MA SM617020007MA SM617020008MA SM617020009MA SM615500007WA SM616150007WA SM616220004WA SM616220005WA SM616220006WA SM616370002WA SM616370003WA SM616370005WA SM616370006WA SM616450003WA SM617030015WA SM617030016WA SM617030017WA SM617040018WA SM617040019WA SM617040020WA SM617040021WA SM617040022WA SM617040023WA SM617060001WA SM617060002WA SM617060003WA SM617060004WA SM617120006WA SM617120007WA SM617080015WA SM617080016WA SM617080017WA SM617080018WA SM617080019WA SM617080020WA SM617080021WA SM617080022WA SM616400019MA SM616400020MA SM616460023MA SM616460024MA SM616460025MA SM616460026MA SM616460027MA SM617050039MA SM616330011WA SM616330012WA SM617040001WA SM615520001WA SM615520002WA SM615520003WA SM616240002WA SM616340049WA SM616340050WA SM616240001WA SM615390002WA SM615390003WA SM615390004WA SM616430045WA SM616430046WA SM616270025WA SM616270026WA SM616220009WA SM616220010WA SM616220011WA SM616340043WA SM615430004WA SM616140005WA SM616140006WA SM616280020WA SM616280021WA SM615390001WA SM616330002WA SM616330003WA SM616330004WA SM616280005WA SM616280006WA SM616280007WA SM616280008WA SM616280009WA SM616280010WA SM616280011WA SM616280012WA SM616280013WA SM616280014WA SM616280015WA SM616280016WA SM616280017WA SM616280018WA SM616280019WA SM616400021WA SM616400022WA SM616400023WA SM616190005WA SM615500005WA SM616210004WA SM616460005WA SM616460006WA SM616460007WA SM616460008WA SM616460009WA SM616320002MA SM616320003MA SM616410012MA SM616410013MA SM616410014MA SM616440003WA SM616500002WA SM616500003WA SM616500004WA SM616510001WA SM616510002WA SM616510003WA SM616510004WA SM616170018WA SM616290001WA SM616030001WA SM616030002WA SM616030003WA SM616030004WA SM616030005WA SM616170007WA SM616440006WA SM616170008WA SM616150014WA SM616350001WA SM616350003WA SM616410025WA SM616410026WA SM617030018WA SM617030019WA SM617030020WA SM617030021WA SM617030022WA SM617030023WA SM617030024WA SM616150013WA SM616290002WA SM616290003WA SM616290004WA SM616290005WA SM616290006WA SM616150010WA SM616170010WA SM616170011WA SM616170012WA SM616170013WA SM616410031WA SM616410039WA SM616410040WA SM616150011WA SM616150012WA SM617040011WA SM617040013WA SM616290007WA SM616350004WA SM616410002WA SM616410023WA SM616410027WA SM616410028WA SM616410029WA SM616410036WA SM616420001WA SM616430041WA SM616430060WA SM
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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