FDAFDA · Alimentos y medicamentos·N.º oficial Z-2508-2020
Azure S DR MRI, Model Number W3DR01
Publicado el 15 de julio de 2020 · Inicio del retiro: 4 de junio de 2020
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
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Distribuidor
- worldwide
- Lote
- serial numbers: RNJ200027H RNJ200025H RNJ200023H RNJ200022H RNJ200020H RNJ200018H RNJ200017H RNJ200015H RNJ200014H RNJ200011H RNJ200009H RNJ200008H RNJ200007H RNJ200006H RNJ200005H RNJ200004H RNJ200086H RNJ200085H RNJ200084H RNJ200083H RNJ200082H RNJ200081H RNJ200080H RNJ200078H RNJ200077H RNJ200076H RNJ200075H RNJ200074H RNJ200073H RNJ200072H RNJ200071H RNJ200070H RNJ200069H RNJ200068H RNJ200067H RNJ200066H RNJ200064H RNJ200063H RNJ200062H RNJ200061H RNJ200060H RNJ200059H RNJ200058H RNJ200057H RNJ200056H RNJ200055H RNJ200054H RNJ200052H RNJ200051H RNJ200050H RNJ200049H RNJ200048H RNJ200047H RNJ200046H RNJ200045H RNJ200043H RNJ200041H RNJ200040H RNJ200039H RNJ200038H RNJ200037H RNJ200036H RNJ200035H RNJ200034H RNJ200033H RNJ200032H RNJ200031H RNJ200030H RNJ200029H RNJ200028H RNJ200145H RNJ200144H RNJ200143H RNJ200142H RNJ200141H RNJ200140H RNJ200139H RNJ200138H RNJ200137H RNJ200135H RNJ200134H RNJ200133H RNJ200131H RNJ200129H RNJ200128H RNJ200127H RNJ200126H RNJ200125H RNJ200124H RNJ200123H RNJ200122H RNJ200121H RNJ200120H RNJ200119H RNJ200118H RNJ200117H RNJ200116H RNJ200115H RNJ200114H RNJ200113H RNJ200112H RNJ200111H RNJ200110H RNJ200107H RNJ200105H RNJ200104H RNJ200103H RNJ200102H RNJ200101H RNJ200100H RNJ200098H RNJ200097H RNJ200096H RNJ200095H RNJ200093H RNJ200092H RNJ200091H RNJ200090H RNJ200089H RNJ200088H RNJ200087H RNJ204130H RNJ203325H RNJ200203H RNJ200202H RNJ200200H RNJ200199H RNJ200198H RNJ200197H RNJ200196H RNJ200195H RNJ200194H RNJ200193H RNJ200192H RNJ200191H RNJ200190H RNJ200189H RNJ200187H RNJ200186H RNJ200185H RNJ200184H RNJ200183H RNJ200182H RNJ200181H RNJ200180H RNJ200178H RNJ200177H RNJ200176H RNJ200175H RNJ200174H RNJ200173H RNJ200172H RNJ200171H RNJ200170H RNJ200169H RNJ200168H RNJ200167H RNJ200166H RNJ200165H RNJ200164H RNJ200163H RNJ200162H RNJ200160H RNJ200159H RNJ200158H RNJ200157H RNJ200156H RNJ200155H RNJ200154H RNJ200152H RNJ200151H RNJ200150H RNJ200149H RNJ200148H RNJ200147H RNJ200146H RNJ200439H RNJ200262H RNJ200261H RNJ200260H RNJ200259H RNJ200258H RNJ200257H RNJ200255H RNJ200254H RNJ200252H RNJ200250H RNJ200249H RNJ200248H RNJ200247H RNJ200246H RNJ200245H RNJ200244H RNJ200243H RNJ200242H RNJ200241H RNJ200240H RNJ200239H RNJ200238H RNJ200237H RNJ200235H RNJ200234H RNJ200233H RNJ200232H RNJ200231H RNJ200230H RNJ200229H RNJ200228H RNJ200227H RNJ200226H RNJ200225H RNJ200224H RNJ200223H RNJ200221H RNJ200220H RNJ200219H RNJ200218H RNJ200216H RNJ200215H RNJ200214H RNJ200212H RNJ200211H RNJ200210H RNJ200209H RNJ200208H RNJ200207H RNJ200206H RNJ200205H RNJ200204H RNJ200321H RNJ200320H RNJ200319H RNJ200318H RNJ200317H RNJ200316H RNJ200315H RNJ200314H RNJ200313H RNJ200312H RNJ200311H RNJ200310H RNJ200309H RNJ200308H RNJ200307H RNJ200306H RNJ200305H RNJ200304H RNJ200303H RNJ200301H RNJ200300H RNJ200299H RNJ200298H RNJ200297H RNJ200296H RNJ200295H RNJ200294H RNJ200293H RNJ200292H RNJ200291H RNJ200290H RNJ200289H RNJ200288H RNJ200286H RNJ200285H RNJ200284H RNJ200283H RNJ200281H RNJ200280H RNJ200279H RNJ200278H RNJ200277H RNJ200275H RNJ200274H RNJ200273H RNJ200272H RNJ200271H RNJ200270H RNJ200269H RNJ200267H RNJ200266H RNJ200265H RNJ200264H RNJ200263H RNJ200437H RNJ200436H RNJ200435H RNJ200434H RNJ200433H RNJ200432H RNJ200431H RNJ200430H RNJ200429H RNJ200428H RNJ200427H RNJ200426H RNJ200425H RNJ200424H RNJ200423H RNJ200419H RNJ200417H RNJ200416H RNJ200415H RNJ200414H RNJ200413H RNJ200412H RNJ200411H RNJ200410H RNJ200409H RNJ200404H RNJ203314H RNJ203313H RNJ200452H RNJ200408H RNJ200407H RNJ200406H RNJ200405H RNJ200403H RNJ200402H RNJ200401H RNJ200400H RNJ200398H RNJ200396H RNJ200395H RNJ200394H RNJ200393H RNJ200392H RNJ200391H RNJ200390H RNJ200389H RNJ200388H RNJ200387H RNJ200386H
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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