FDAFDA · Alimentos y medicamentos·N.º oficial Z-0614-2024
Medtronic SynchroMed II, Model 8637-20, Programmable pump
Publicado el 3 de enero de 2024 · Inicio del retiro: 13 de noviembre de 2023
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Medtronic Neuromodulation
- Distribuidor
- Worldwide
- Lote
- GTIN 00613994518781, Serial Numbers: NGP756746H, NGP000266H, NGP000270H, NGP000273H, NGP000274H, NGP000276H, NGP000292H, NGP000293H, NGP000312H, NGP000513H, NGP000515H, NGP000516H, NGP000589H, NGP000591H, NGP000592H, NGP000595H, NGP000596H, NGP000597H, NGP000598H, NGP000599H, NGP000600H, NGP000601H, NGP000602H, NGP000603H, NGP000604H, NGP000605H, NGP000606H, NGP000607H, NGP001428H, NGP001466H, NGP001467H, NGP001469H, NGP001471H, NGP001472H, NGP001473H, NGP001475H, NGP001476H, NGP001477H, NGP001479H, NGP001480H, NGP001482H, NGP001483H, NGP001484H, NGP001485H, NGP001487H, NGP001488H, NGP001489H, NGP001490H, NGP001491H, NGP001492H, NGP001493H, NGP001494H, NGP001495H, NGP001496H, NGP001498H, NGP001499H, NGP001500H, NGP001501H, NGP001502H, NGP001684H, NGP001685H, NGP001686H, NGP001688H, NGP001689H, NGP001692H, NGP001695H, NGP001696H, NGP001697H, NGP001698H, NGP001699H, NGP001700H, NGP001701H, NGP001703H, NGP001704H, NGP001705H, NGP001706H, NGP001707H, NGP001708H, NGP003370H, NGP003371H, NGP003372H, NGP003374H, NGP003375H, NGP003376H, NGP003378H, NGP003379H, NGP003382H, NGP003383H, NGP003384H, NGP003385H, NGP003386H, NGP003387H, NGP003388H, NGP003389H, NGP003391H, NGP003392H, NGP003393H, NGP003394H, NGP003396H, NGP003397H, NGP003398H, NGP003399H, NGP003400H, NGP003401H, NGP003402H, NGP003403H, NGP003404H, NGP003405H, NGP003406H, NGP003407H, NGP003408H, NGP003409H, NGP004884H, NGP004885H, NGP004886H, NGP004887H, NGP004888H, NGP004889H, NGP004890H, NGP004891H, NGP004892H, NGP004893H, NGP004894H, NGP004895H, NGP004896H, NGP004899H, NGP004900H, NGP004905H, NGP004906H, NGP004912H, NGP004913H, NGP004916H, NGP004919H, NGP004924H, NGP004925H, NGP004926H, NGP004968H, NGP004969H, NGP004971H, NGP004973H, NGP004975H, NGP004976H, NGP004977H, NGP004978H, NGP004979H, NGP004980H, NGP004983H, NGP004984H, NGP004986H, NGP004987H, NGP004991H, NGP005000H, NGP005001H, NGP005003H, NGP005004H, NGP005005H, NGP005006H, NGP005007H, NGP005009H, NGP005010H, NGP005011H, NGP005012H, NGP005013H, NGP005014H, NGP005016H, NGP412982H, NGP412983H, NGP412984H, NGP412988H, NGP412991H, NGP412992H, NGP412996H, NGP412999H, NGP413002H, NGP413009H, NGP413015H, NGP413018H, NGP413028H, NGP413032H, NGP413038H, NGP413062H, NGP413065H, NGP413066H, NGP413217H, NGP413218H, NGP413238H, NGP413276H, NGP413284H, NGP413289H, NGP413290H, NGP413291H, NGP413328H, NGP413364H, NGP413384H, NGP413393H, NGP413396H, NGP413410H, NGP413419H, NGP413420H, NGP413448H, NGP413454H, NGP413477H, NGP413486H, NGP413534H, NGP413568H, NGP413819H, NGP413822H, NGP413844H, NGP413846H, NGP414041H, NGP414078H, NGP414117H, NGP414152H, NGP414391H, NGP414405H, NGP414546H, NGP414547H, NGP414549H, NGP414550H, NGP414551H, NGP414553H, NGP414555H, NGP414559H, NGP414560H, NGP414562H, NGP414565H, NGP414571H, NGP414572H, NGP414573H, NGP414574H, NGP414575H, NGP414580H, NGP414581H, NGP414582H, NGP414583H, NGP414634H, NGP414745H, NGP414842H, NGP415128H, NGP415130H, NGP415131H, NGP415133H, NGP415134H, NGP415135H, NGP415136H, NGP415137H, NGP415139H, NGP415143H, NGP415144H, NGP415146H, NGP415147H, NGP415148H, NGP415149H, NGP415150H, NGP415151H, NGP415152H, NGP415153H, NGP415673H, NGP415674H, NGP416897H, NGP417710H, NGP417711H, NGP417712H, NGP417714H, NGP417715H, NGP417717H, NGP417719H, NGP417721H, NGP417744H, NGP417745H, NGP417746H, NGP417747H, NGP417748H, NGP417749H, NGP417750H, NGP417751H, NGP417752H, NGP417753H, NGP417754H, NGP417755H, NGP417756H, NGP417757H, NGP417758H, NGP417759H, NGP417760H, NGP417761H, NGP417762H, NGP417763H, NGP418733H, NGP418735H, NGP418736H, NGP418737H, NGP418738H, NGP418739H, NGP418740H, NGP418741H, NGP418742H, NGP418743H, NGP418744H, NGP418745H, NGP418746H, NGP418748H, NGP418749H, NGP418750H, NGP418751H, NGP418752H, NGP418753H, NGP419605H, NGP419606H, NGP419607H, NGP419608H, NGP419609H, NGP419610H, NGP419611H, NGP419614H, NGP419615H, NGP419616H, NGP419617H, NGP419619H, NGP419620H, NGP419621H, NGP419622H, NGP419623H, NGP420910H, NGP420913H, NGP420918H, NGP420919H, NGP420920H, NGP420924H, NGP420925H, NG
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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