FDAFDA · Alimentos y medicamentos·N.º oficial Z-0421-2024
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
Publicado el 6 de diciembre de 2023 · Inicio del retiro: 3 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
It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to device position/migration, patient activity, or external electromagnetic interference.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Medtronic Inc.
- Distribuidor
- US and Australia, Austria, Belgium, Brunei Darussalam, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Liechtenstein, Luxembourg, Macao, Malaysia, Netherlands, New Zealand, Northern Ireland, Norway, Portugal, Puerto Rico, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom
- Lote
- GTIN 00763000060374, Serial Numbers: RLB088215G, RLB088216G, RLB088218G, RLB091019G, RLB034146G, RLB087479G, RLB127232G, RLB096039G, RLB086587G, RLB086621G, RLB088233G, RLB088236G, RLB088253G, RLB123314G, RLB043944G, RLB043960G, RLB064996G, RLB132967G, RLB100312G, RLB129506G, RLB100832G, RLB133215G, RLB135262G, RLB095554G, RLB085079G, RLB085091G, RLB076831G, RLB039020G, RLB039027G, RLB039991G, RLB067804G, RLB067902G, RLB068380G, RLB046661G, RLB046706G, RLB032307G, RLB051206G, RLB059647G, RLB059927G, RLB059929G, RLB057274G, RLB057275G, RLB057281G, RLB049542G, RLB049547G, RLB049558G, RLB050122G, RLB050400G, RLB135044G, RLB135571G, RLB116211G, RLB116212G, RLB116278G, RLB132853G, RLB041540G, RLB080621G, RLB128220G, RLB044256G, RLB045549G, RLB045551G, RLB131768G, RLB067275G, RLB067283G, RLB076103G, RLB097835G, RLB123630G, RLB123632G, RLB123637G, RLB124673G, RLB073925G, RLB079721G, RLB082968G, RLB090643G, RLB047705G, RLB050161G, RLB051708G, RLB071194G, RLB074924G, RLB040742G, RLB040745G, RLB040747G, RLB042297G, RLB042305G, RLB126760G, RLB049893G, RLB056158G, RLB060723G, RLB067531G, RLB072387G, RLB077136G, RLB081270G, RLB074296G, RLB074299G, RLB074311G, RLB079205G, RLB079211G, RLB079220G, RLB081471G, RLB079130G, RLB079191G, RLB075572G, RLB075573G, RLB075791G, RLB046637G, RLB046831G, RLB046834G, RLB046839G, RLB046842G, RLB064638G, RLB064714G, RLB064723G, RLB064727G, RLB064729G, RLB072023G, RLB072026G, RLB072042G, RLB072045G, RLB073339G, RLB046700G, RLB046701G, RLB046707G, RLB046708G, RLB061262G, RLB061263G, RLB061471G, RLB062138G, RLB062262G, RLB067104G, RLB067110G, RLB067140G, RLB068189G, RLB069163G, RLB054816G, RLB054863G, RLB054781G, RLB054783G, RLB054785G, RLB059008G, RLB059009G, RLB062338G, RLB062068G, RLB062077G, RLB062079G, RLB062084G, RLB062085G, RLB062149G, RLB062150G, RLB060825G, RLB060834G, RLB054129G, RLB054137G, RLB054138G, RLB051687G, RLB050246G, RLB050253G, RLB050255G, RLB050283G, RLB050039G, RLB050053G, RLB050056G, RLB050057G, RLB050357G, RLB048507G, RLB048511G, RLB048512G, RLB048519G, RLB048521G, RLB037368G, RLB039661G, RLB039662G, RLB039666G, RLB039669G, RLB039718G, RLB039720G, RLB039721G, RLB040266G, RLB040269G, RLB036841G, RLB036845G, RLB037212G, RLB037622G, RLB038062G, RLB037854G, RLB037896G, RLB037918G, RLB037919G, RLB037925G, RLB037927G, RLB037931G, RLB038281G, RLB038284G, RLB038815G, RLB038963G, RLB038972G, RLB034079G, RLB034209G, RLB034211G, RLB038014G, RLB039063G, RLB032205G, RLB032219G, RLB032231G, RLB032232G, RLB032583G, RLB033606G, RLB033673G, RLB033906G, RLB033952G, RLB034021G, RLB033563G, RLB033675G, RLB033678G, RLB033679G, RLB033680G, RLB030619G, RLB031105G, RLB031107G, RLB031118G, RLB031127G, RLB031366G, RLB032071G, RLB032076G, RLB032082G, RLB032126G, RLB030444G, RLB030446G, RLB030456G, RLB033085G, RLB033096G, RLB030729G, RLB030733G, RLB031213G, RLB031259G, RLB031262G, RLB030189G, RLB030198G, RLB030208G, RLB030209G, RLB030211G, RLB030215G, RLB030216G, RLB030236G, RLB030240G, RLB030245G, RLB030296G, RLB030299G, RLB030326G, RLB030350G, RLB030351G, RLB030476G, RLB030486G, RLB030510G, RLB030512G, RLB030516G, RLB062176G, RLB062725G, RLB062734G, RLB056351G, RLB084344G, RLB084995G, RLB085128G, RLB087056G, RLB087073G, RLB087076G, RLB088090G, RLB088527G, RLB088528G, RLB088680G, RLB077294G, RLB080398G, RLB124826G, RLB042637G, RLB126567G, RLB056368G, RLB066461G, RLB070198G, RLB123329G, RLB123352G, RLB124202G, RLB126785G, RLB126787G, RLB126793G, RLB126794G, RLB126800G, RLB073358G, RLB091205G, RLB074046G, RLB079395G, RLB071122G, RLB071125G, RLB050619G, RLB050620G, RLB066974G, RLB067045G, RLB067731G, RLB069567G, RLB054719G, RLB054724G, RLB056208G, RLB056215G, RLB058914G, RLB058915G, RLB058916G, RLB058931G, RLB062130G, RLB062291G, RLB062293G, RLB062303G, RLB038599G, RLB038665G, RLB100059G, RLB066997G, RLB067306G, RLB067729G, RLB067732G, RLB067735G, RLB073461G, RLB073496G, RLB073506G, RLB073511G, RLB090396G, RLB090397G, RLB090542G, RLB090545G, RLB090549G, RLB090550G, RLB090552G, RLB090553G, RLB044412G, RLB070083G, RL
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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