FDAFDA · Alimentos y medicamentos·N.º oficial Z-0919-2022
MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
Publicado el 20 de abril de 2022 · Inicio del retiro: 16 de marzo de 2022
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
Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare, LLC
- Distribuidor
- US and Australia, Austria, Bahrain, Belgium, Brazil, Canada, Denmark, England, France, Germany, Ireland, Italy, Korea, Malaysia, Netherlands, Norway, Poland, Qatar, Saudi Arabia, Singapore, Spain, Sweden, Taiwan, Turkey
- Lote
- a) 3101011-040, UDI (01)00840682142809(10)MUSENXSP2, Serial Numbers: SSR20435644TA, SSR20085352TA, SSR19455267TA, SSR20245386TA, SSR20225354TA, SSR20235322TA, SSR19485286TA, SSR20265441TA, SSR20435653TA, SSR20235349TA, SSR20315513TA, SSR20045337TA, SSR19415230TA, SSR19425238TA; UDI (01)00840682142809(10)MUSENXSP3, Serial Numbers: SSR19305164TA, SSR21255865TA, SSR20525351TA, SSR20525347TA, SSR20325524TA, SSR21326015TA, SSR21025368TA, SSR21065487TA, SSR19395224TA; UDI (01)00840682142809(10)MUSENXSP4, Serial Numbers: SSR19445252TA, SSR21035400TA, SSR21536318TA, SSR22056438TA, SSR20225343TA, SSR20515315TA, SSR20265429TA, SSR20465706TA, SSR20315501TA b) 3101010-401, UDI (01)00840682142809(10)MUSENXSP2, Serial Numbers: SSR19305178TA, SSR19265115TA, SSR20315505TA, SSR20405600TA, SSR20415608TA, SSR20255413TA, SSR20385590TA, SSR20265439TA, SSR19485282TA, SSR19435251TA, SSR20235360TA, SSR20125313TA, SSR20325529TA, SSR20125350TA, SSR19445257TA, SSR20035336TA, SSR19515306TA, SSR19415228TA, SSR20235369TA, SSR20355576TA, SSR20515344TA, SSR20225349TA, SSR20415610TA, SSR20335533TA, SSR20235365TA, SSR20425623TA, SSR19525317TA, SSR20235346TA; UDI (01)00840682142809(10)MUSENXSP3, Serial Numbers: SSR21185714TA, SSR19285150TA, SSR21085519TA, SSR21356058TA, SSR20455682TA, SSR21215784TA, SSR21275895TA, SSR21285908TA, SSR21205767TA, SSR20295480TA, SSR21045424TA, SSR21175691TA, SSR21055448TA, SSR19355213TA, SSR21065475TA, SSR21055459TA, SSR21165669TA, SSR21185705TA, SSR21195741TA, SSR21125596TA, SSR21235844TA, SSR20465707TA, SSR21315999TA, SSR21426117TA, SSR21155657TA, SSR21426114TA, SSR21035404TA, SSR21295941TA, SSR20235345TA, SSR21055456TA, SSR20315499TA, SSR20315500TA, SSR20275464TA, SSR21185719TA, SSR21185720TA, SSR21386052TA, SSR21386053TA, SSR21386054TA, SSR21436118TA, SSR21436122TA, SSR21436123TA, SSR20235325TA, SSR21185731TA, SSR20315494TA, SSR20315493TA, SSR20265446TA, SSR21356057TA; UDI (01)00840682142809(10)MUSENXSP4, Serial Numbers: SSR21476197TA, SSR21305971TA, SSR21506267TA, SSR21185730TA, SSR21396072TA, SSR21486216TA, SSR21476205TA, SSR21356047TA, SSR21215780TA, SSR21506263TA, SSR21225815TA, SSR21496242TA, SSR21526307TA, SSR19505289TA, SSR21516287TA, SSR22046398TA, SSR21516281TA, SSR21526299TA, SSR21416095TA, SSR21235846TA, SSR21336022TA, SSR20295484TA, SSR21275889TA, SSR21496247TA, SSR22096508TA, SSR21506252TA, SSR21466153TA, SSR22066453TA; c) 3101010-009, UDI (01)00840682142809(10)MUSENXSP3, Serial Numbers: SSR21095569TA, SSR21135614TA, SSR21025386TA; UDI (01)00840682142809(10)MUSENXSP4, Serial Numbers: SSR22026369TA, SSR22046388TA; d) 3101010-008, UDI (01)00840682142809(10)MUSENXSP2, Serial Numbers: SSR20235354TA, SSR20505775TA, SSR20255408TA; UDI (01)00840682142809(10)MUSENXSP3, Serial Numbers: SSR21366065TA, SSR21065468TA, SSR21316007TA; UDI (01)00840682142809(10)MUSENXSP4, Serial Numbers: SSR21486211TA
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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