FDAFDA · Alimentos y medicamentos·N.º oficial Z-2377-2018
Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754
Publicado el 11 de julio de 2018 · Inicio del retiro: 24 de abril de 2018
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
The MiniMed Paradigm Veo insulin pump has an error that impacts the Arabic language translation.This translation error occurs in the Predictive Alerts setting screen, which allows user to program alerts that will sound if users are predicted to reach their pre-set low or high sensor glucose values.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Medtronic Inc.
- Distribuidor
- International only. No U.S. distribution
- Lote
- Lot Serial # PAR602720U PAR602721U PAR602727U PAR602734U PAR602736U PAR602739U PAR602740U PAR602741U PAR602743U PAR602746U PAR602747U PAR602748U PAR602750U PAR602751U PAR602755U PAR602758U PAR602759U PAR602897U PAR604895U PAR604907U PAR604917U PAR607172U PAR607201U PAR607235U PAR608710U PAR608715U PAR608724U PAR615861U PAR615862U PAR615866U PAR615869U PAR615870U PAR615871U PAR615873U PAR615878U PAR615889U PAR615894U PAR615903U PAR780320H PAR780365H PAR780392H PAR780396H PAR785836H PAR785915H PAR785925H PAR786247H PAR786265H PAR786338H PAR786340H PAR791069H PAR796167H PAR797220H PAR797230H PAR797859H PAR797907H PAR797912H PAR800371H PAR800376H PAR800392H PAR800919H PAR800934H PAR802059H PAR806151H PAR806153H PAR806157H PAR806158H PAR806159H PAR806160H PAR806162H PAR825168H PAR827543H PAR843509H PAR843510H PAR843511H PAR843512H PAR843522H PAR843525H PAR843530H PAR843531H PAR843534H PAR843535H PAR843538H PAR843539H PAR843547H PAR843551H PAR843555H PAR843556H PAR843557H PAR843580H PAR843592H PAR843593H PAR843594H PAR843595H PAR843596H PAR843597H PAR843599H PAR843601H PAR843602H PAR843603H PAR843604H PAR843605H PAR843607H PAR843610H PAR843611H PAR843612H PAR843728H PAR843739H PAR843741H PAR843749H PAR843758H PAR844361H PAR844362H PAR844365H PAR844367H PAR844368H PAR844371H PAR844372H PAR844373H PAR844375H PAR844378H PAR844381H PAR844387H PAR844477H PAR844482H PAR844484H PAR844488H PAR844494H PAR844501H PAR844971H PAR845708H PAR845785H PAR845789H PAR845792H PAR845793H PAR845795H PAR845796H PAR845797H PAR845799H PAR845800H PAR845803H PAR845805H PAR845810H PAR845811H PAR845813H PAR845817H PAR845820H PAR845826H PAR845828H PAR845831H PAR845834H PAR845837H PAR845839H PAR845840H PAR845841H PAR845844H PAR846178H PAR846179H PAR846189H PAR846208H PAR846416H PAR846425H PAR846435H PAR846472H PAR847477H PAR847480H PAR847491H PAR847492H PAR847494H PAR847500H PAR847511H PAR847512H PAR847513H PAR847515H PAR847516H PAR847518H PAR847521H PAR847524H PAR847525H PAR847533H PAR847534H PAR847541H PAR847550H PAR847553H PAR847554H PAR847555H PAR847558H PAR847561H PAR847563H PAR847567H PAR847573H PAR847578H PAR847581H PAR847587H PAR847588H PAR847590H PAR847591H PAR847592H PAR847593H PAR847597H PAR847598H PAR847602H PAR847603H PAR847604H PAR847606H Lot Serial # PAR847615H PAR847622H PAR847623H PAR847626H PAR847627H PAR849065H PAR849066H PAR849067H PAR849068H PAR849069H PAR849070H PAR849072H PAR849073H PAR849075H PAR849076H PAR849078H PAR849079H PAR849623H PAR849631H PAR849633H PAR849634H PAR849640H PAR849643H PAR849656H PAR849658H PAR849659H PAR849661H PAR849664H PAR849669H PAR849681H PAR849684H PAR849688H PAR849689H PAR849695H PAR849696H PAR849697H PAR849699H PAR849700H PAR849705H PAR849706H PAR849707H PAR849709H PAR849715H PAR849726H PAR849731H PAR849737H PAR849738H PAR849741H PAR849742H PAR849743H PAR850279H PAR850407H PAR855001H PAR855011H PAR856006H PAR856007H PAR856218H PAR856238H PAR856240H PAR859498H PAR859743H PAR859756H PAR859757H PAR859774H PAR859778H PAR859779H PAR859792H PAR865685H Lot Serial # PAR878523H PAR878539H PAR888917H PAR888933H PAR888935H PAR889747H PAR889751H PAR889753H PAR889755H PAR889771H PAR889774H PAR889784H PAR890416H PAR891498H PAR892800H PAR892807H PAR892834H PAR892858H PAR894611H PAR894613H PAR901148H PAR902548H PAR902555H PAR902709H PAR903622H PAR903627H PAR903628H PAR903630H PAR903633H PAR903635H PAR903639H PAR903642H PAR903644H PAR904601H PAR916689H PAR918399H PAR918466H PAR918470H PAR918475H PAR918486H PAR918493H PAR918502H PAR918518H PAR918564H PAR919784H PAR919816H PAR919827H PAR919844H PAR919850H PAR920893H PAR920900H PAR920906H PAR920918H PAR920921H PAR920924H PAR920964H PAR922144H PAR922324H
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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