Volver al buscador
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

¿Vendes productos como este?

Recalert vigila todo tu catálogo contra retiros como este, automáticamente.

Empezar gratis — sin tarjeta