FDAFDA · Alimentos y medicamentos·N.º oficial Z-0965-2013
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
Publicado el 27 de marzo de 2013 · Inicio del retiro: 1 de marzo de 2013
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
An internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. Should this occur, the defibrillator would not be able to deliver therapy or communicate with the Q-TECH Model 2020 programmer, and would be unable to emit tones or otherwise respond to magnet application.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Boston Scientific CRM Corp
- Distribuidor
- Worldwide Distribution, USA including the states of AZ, CA, CO, DC, GA, IL, MD, MA, MN, NJ, NY, NC, OH, PA, SC, VA, WA and the countries of AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IRELAND, ITALY, NETHERLANDS, NEW ZEALAND, PORTUGAL, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, and the UNITED KINGDOM.
- Lote
- SERIAL NUMBERS A002804 A003105 A001493 A001784 A001981 A003024 A003197 A001609 A001594 A001733 A002291 A002348 A002373 A002195 A002710 A004131 A001942 A002278 A002399 A002402 A001021 A001136 A001104 A001193 A001392 A002093 A002147 A001134 A001155 A001063 A001011 A001102 A001012 A001004 A001058 A001010 A001140 A001093 A001170 A001055 A001185 A001144 A001217 A001215 A001241 A001367 A001377 A001405 A001431 A001380 A001468 A001411 A001639 A001688 A001734 A001578 A001654 A001799 A001916 A001903 A002127 A002076 A002425 A002686 297-899 300-895 292-887 A001120 A001085 A001109 A001089 A001122 A001110 A001020 A001052 A001023 A001051 A001062 A001148 A001042 A001106 A001091 A001096 A001126 A001237 A001341 A001354 A001447 A001429 A001533 A001481 A001236 A001119 A001246 A001384 A001267 A001731 A001650 A001774 A001856 A001980 A001752 A002364 A002823 A002826 A002833 A002858 A002889 A002892 A002946 A002997 A002996 A002953 A003386 A003465 A003066 A003382 A003426 A003540 A003563 A001291 A001463 A002985 A001146 A001174 A001040 A001005 A001053 A001180 A001195 A001194 A001188 A001233 A001270 A001273 A001197 A001294 A001368 A001338 A001332 A001152 A001423 A001344 A001443 A001235 A001317 A001363 A001512 A001513 A001538 A001489 A001480 A001334 A001500 A001820 A001680 A001647 A001652 A001630 A001696 A001789 A001740 A001781 A001271 A001711 A001661 A001573 A001772 A001636 A001682 A001750 A001437 A001882 A002050 A002036 A002045 A001910 A002015 A001888 A002068 A001605 A002005 A001860 A002234 A002300 A002337 A002087 A002295 A002272 A002141 A002261 A002243 A001958 A002266 A002014 A002071 A001768 A002158 A002286 A002403 A002194 A002228 A002292 A002418 A002252 A002342 A002459 A002374 A002424 A002485 A002276 A002523 A002027 A002376 A002672 A002645 A002267 A002553 A002608 A002737 A002999 A003124 A003138 A003285 A003449 A004002 A003886 A003694 A003842 A001732 A001660 A001800 A001427 A001418 A001428 A001441 A001454 A001635 A001566 A001697 A001653 A001634 A001811 A001623 A001837 A001793 A001745 A001905 A001863 A001867 A001887 A001588 A001808 A001953 A001859 A001690 A001729 A001692 A001872 A001871 A001908 A001822 A002013 A001550 A002083 A001932 A001952 A001923 A002095 A001832 A002134 A002135 A001824 A002003 A001875 A001987 A001853 A001850 A001817 A001975 A001739 A002082 A002111 A002017 A001896 A001843 A002165 A001920 A001990 A001695 A001962 A002102 A002339 A001801 A002113 A002136 A002084 A002235 A002105 A002150 A002143 A002118 A002022 A002204 A002211 A002069 A001963 A001970 A001861 A002210 A002397 A001847 A002101 A002131 A002157 A001960 A002232 A002098 A002103 A001985 A001629 A002175 A001792 A002160 A002249 A002250 A002199 A002188 A002289 A002318 A002400 A002110 A002242 A002254 A002213 A002312 A002223 A001921 A002224 A002393 A002077 A002075 A002315 A002361 A001993 A002251 A002226 A002420 A002156 A002245 A002125 A001876 A002177 A002370 A002241 A002230 A001865 A002427 A001597 A002416 A001753 A002338 A002369 A002454 A001727 A002349 A002423 A002326 A002203 A002434 A002458 A002461 A002382 A002407 A002336 A002575 A002323 A002537 A002499 A002139 A002356 A002367 A002438 A002383 A002448 A002457 A002647 A001787 A002311 A002408 A002661 A002529 A001880 A002255 A002554 A002299 A002595 A002366 A002006 A002675 A002462 A002325 A002592 A002653 A002507 A002616 A002472 A002107 A002428 A002117 A002603 A002715 A002572 A002587 A002417 A002586 A002598 A002582 A002535 A002629 A002617 A002518 A002599 A002649 A002638 A002679 A002631 A002431 A002774 A002779 A002551 A002716 A002557 A002628 A002640 A002687 A002803 A002677 A002761 A002786 A002784 A002674 A00269
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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