FDAFDA · Alimentos y medicamentos·N.º oficial Z-0180-2015
Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Publicado el 17 de diciembre de 2014 · Inicio del retiro: 1 de octubre 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
Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter PCBA where a capacitor component can fail, causing a dim but functional screen and thermal odor.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- Distribuidor
- Worldwide Distribution-US (nationwide) including the states of CA, CO, FL, GA, KY, MA, MN, NC, NY, OH, OK, PA, SC, TN, TX, UT, and WI, and the countries of Canada, Mexico, Saudi Arabia, South Africa and United Arab Emirates.
- Lote
- Model number PB980 Ventilator:35B1400143, 35B1400684, 35B1400627, 35B1400708, 35B1400398, 35B1400482, 35B1400491, 35B1400512, 35B1400601, 35B1400121, 35B1400568, 35B1400590, 35B1400595, 35B1400599, 35B1400606, 35B1400106, 35B1400146, 35B1400169, 35B1400226, 35B1400260, 35B1400270, 35B1400263, 35B1400351, 35B1400373, 35B1400400, 35B1400401, 35B1400608, 35B1400089, 35B1400112, 35B1400683, 35B1400685, 35B1400678, 35B1400118, 35B1400114, 35B1400355, 35B1400144, 35B1400300, 35B1400379, 35B1400412, 35B1400472, 35B1400489, 35B1400490, 35B1400492, 35B1400493, 35B1400499, 35B1400500, 35B1400501, 35B1400502, 35B1400507, 35B1400577, 35B1400207, 35B1400211, 35B1400216, 35B1400222, 35B1400225, 35B1400231, 35B1400267, 35B1400312, 35B1400323, 35B1400340, 35B1400383, 35B1400128, 35B1400363, 35B1400459, 35B1400589, 35B1400616, 35B1400637, 35B1400483, 35B1400311, 35B1400447, 35B1400648, 35B1400651, 35B1400654, 35B1400662, 35B1400686, 35B1400692, 35B1400175, 35B1400294, 35B1400436, 35B1400485, 35B1400586, 35B1400644, 35B1400687, 35B1400689, 35B1400694, 35B1400700, 35B1400661, 35B1400676, 35B1400693, 35B1400732, 35B1400734, 35B1400736, 35B1400737, 35B1400742, 35B1400280, 35B1400360, 35B1400471, 35B1400609, 35B1400674, 35B1400688, 35B1400755, 35B1400480, 35B1400675, 35B1400706, 35B1400771, 35B1400667, 35B1400704, 35B1400705, 35B1400727, 35B1400743, 35B1400279, 35B1400285, 35B1400262, 35B1400265, 35B1400259, 35B1400494, 35B1400403, 35B1400779, 35B1400783, 35B1400509, 35B1400724, 35B1400763, 35B1400767, 35B1400566, 35B1400768, 35B1400772, 35B1400791, 35B1400793, 35B1400817, 35B1400525, 35B1400796, 35B1400801, 35B1400809, 35B1400821, 35B1400828, 35B1400333, 35B1400366, 35B1400392, 35B1400440, 35B1400463, 35B1400478, 35B1400308, 35B1400347, 35B1400367, 35B1400396, 35B1400078, 35B1400099, 35B1400130, 35B1400155, 35B1400157, 35B1400158, 35B1400174, 35B1400176, 35B1400178, 35B1400180, 35B1400281, 35B1400315, 35B1400631, 35B1400635, 35B1400625, 35B1400653, 35B1400843, 35B1400847, 35B1400233, 35B1400271, 35B1400337, 35B1400350, 35B1400359, 35B1400368, 35B1400384, 35B1400468, 35B1400486, 35B1400495, 35B1400094, 35B1400236, 35B1400437, 35B1400438, 35B1400479, 35B1400496, 35B1400505, 35B1400506, 35B1400427, 35B1400511, 35B1400325, 35B1400462, 35B1400514, 35B1400536, 35B1400537, 35B1400544, 35B1400066, 35B1400200, 35B1400782, 35B1400829, 35B1400015, 35B1400110, 35B1400516, 35B1400517, 35B1400859, 35B1400013, 35B1400103, 35B1400167, 35B1400124, 35B1400007, 35B1400058, 35B1400083, 35B1400129, 35B1400132, 35B1400006, 35B1400079, 35B1400113, 35B1400116, 35B1400219, 35B1400163, 35B1400543.
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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