Devices

Device Recall RF Ablation System Foot Switch

  • 모델명 / 제조번호(시리얼번호)
    M004 218400, Serial numbers starting in 0430200, 0530100, 0606100, 0610000, 0620200, 0623700, 0626500, 0629900, 0634800, and ending in 001-405.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- including USA and countries of France, Great Britain, Saudi Arabia, Spain, Canada, Portugal, Germany, Italy, Australia, Russia, Netherlands, Ireland, Libya.
  • 제품 설명
    RF Ablation System Foot Switch. (Can be used with Boston Scientific Maestro 3000 and EPT-1000XP Cardiac Ablation Cardiac Ablation Systems). Manufactured by Altech Corporation, Flemmington NJ and distributed by Boston Scientific Corporation, San Jose, CA, catalog numbers/UPN numbers 21840/M004 218400. || Indicated for use in cardiac ablation procedures.
  • Manufacturer
    Boston Scientific Corp
  • 1 Event

제조사

Boston Scientific Corp
  • 제조사 주소
    Boston Scientific Corp, 150 Baytech Dr, San Jose CA 95134-2302
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA

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Device Recall RF Ablation System Foot Switch, used with the EPT1000 RF Generator
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 49615 56781 57259 59544 61161 62244 62643 62694 62881 63271 49889 56794 57260 59545 61162 62245 62644 62695 62882 63272 49895 56800 57261 59549 61163 62246 62645 62696 62883 63273 50100 56801 57263 59550 61164 62247 62646 62698 62884 63274 50108 56805 57267 59552 61165 62248 62647 62699 62885 63275 50531 56806 57613 59555 61166 62249 62648 62844 62886 63276 50807 56810 58739 59560 61167 62250 62649 62845 62887 63277 51710 56812 58742 59564 61168 62251 62650 62846 62888 63278 52362 56814 58743 59565 61170 62253 62651 62847 62889 63279 52363 56815 58745 59567 61171 62255 62653 62848 62890 63280 52364 56816 58746 59568 61173 62256 62654 62849 62891 63281 52365 56817 59156 59569 61870 62257 62655 62850 62892 63282 52369 57190 59186 59819 61871 62258 62657 62851 62893 63283 52370 57193 59187 61116 61873 62259 62658 62852 62894 63284 52371 57194 59189 61117 61875 62260 62659 62853 62895 63285 52377 57199 59190 61118 61876 62262 62660 62854 62896 63286 52394 57200 59191 61119 61880 62265 62663 62855 62897 63287 52395 57201 59192 61120 61881 62266 62665 62856 62898 63288 52397 57203 59193 61122 61882 62267 62666 62857 62899 63289 53543 57209 59194 61123 61885 62268 62667 62858 62900 63290 54061 57210 59195 61124 61886 62269 62668 62859 62901 63291 54561 57211 59196 61125 61887 62270 62669 62860 62902 63292 54562 57212 59197 61126 61889 62271 62670 62861 62903 63293 54563 57213 59198 61128 61890 62272 62671 62862 62904 63295 54908 57214 59199 61129 61891 62273 62672 62863 62905 63296 54909 57218 59200 61131 61892 62274 62673 62864 62906 63297 54924 57222 59201 61132 61893 62275 62674 62865 62907 63298 55202 57224 59202 61133 61895 62276 62675 62866 62908 63299 55203 57227 59203 61136 61896 62277 62676 62867 62909 63300 55204 57229 59204 61139 61897 62279 62678 62868 62910 63301 55205 57230 59205 61140 61899 62501 62680 62869 62911 63302 55207 57231 59207 61143 61902 62627 62681 62870 62912 63303 55220 57234 59208 61144 61903 62630 62682 62871 62913 63304 56764 57237 59209 61145 61904 62631 62683 62872 62914 63305 56768 57238 59211 61147 61906 62632 62684 62873 62915 63306 56769 57239 59214 61148 62237 62633 62686 62874 62916 63307 56770 57241 59535 61154 62238 62634 62687 62875 62917 63308 56771 57242 59536 61155 62239 62635 62689 62876 62918 63309 56774 57243 59537 61156 62240 62636 62690 62877 63267 63310 56777 57246 59540 61157 62241 62637 62691 62878 63268 63311 56778 57255 59541 61158 62242 62641 62692 62879 63269 63312 56779 57256 59543 61159 62243 62642 62693 62880 63270 63313 63314 63357 64253 64295 64884 64926 90574 91230 91403 91510 63315 63358 64254 64296 64885 64927 90575 91231 91404 91511 63316 63359 64255 64297 64886 64928 90576 91232 91405 91512 63317 63360 64256 64298 64887 64929 90577 91233 91406 91513 63318 63361 64257 64299 64888 64930 90578 91234 91407 91514 63319 63362 64258 64300 64889 64931 90579 91235 91408 91515 63320 63363 64259 64301 64890 64932 90580 91236 91409 91516 63321 63364 64260 64302 64891 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64234 64277 64319 64908 64951 91013 91254 91427 94409 63340 64235 64278 64867 64909 64952 91014 91386 91428 94410 63341 64236 64279 64868 64910 64953 91015 91387 91429 94411 63342 64237 64280 64869 64911 64954 91016 91388 91430 94412 63343 64238 64281 64870 64912 64955 91017 91389 91431 94413 63344 64239 64282 64871 64913 64956 91018 91390 91432 94414 63345 64241 64283 64872 64914 64957 91019 91391 91433 94415 63346 64242 64284 64873 64915 64958 91020 91392 91434 94416 63347 64243 64285 64874 64916 64959 91021 91393 91435 94417 63348 64244 64286 64875 64917 64960 91022 91394 91501 94418 63349 64245 64287 64876 64918 90566 91023 91395 91502 94419 63350 64246 64288 64877 64919 90567 91024 91396 91503 94420 63351 64247 64289 64878 64920 90568 91025 91397 91504 94421 63352 64248 64290 64879 64921 90569 91026 91398 91505 94422 63353 64249 64291 64880 64922 90570 91027 91399 91506 94423 63354 64250 64292 64881 64923 90571 91028 91400 91507 94424 63355 64251 64293 64882 64924 90572 91029 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071601-009 2318284 3049210 010702-008 031299-012 041601-003 071601-010 2415609 3049213 010702-009 031299-014 041601-004 081701-001 2415610 3076854 010702-011 032900-004 041601-005 082301-031 2520150 3076857 011502-003 032900-005 050801-001 082301-032 2520151 3076858 011502-004 032900-006 050801-002 082301-033 2520152 3217687 011502-005 032900-007 050801-003 082301-034 2520153 3217688 020199-001 032900-008 050801-004 090399-010 2891036 3295978 020199-003 032900-010 050801-005 091801-002 2891037 3295982 020199-004 032900-011 061801-001 111599-001 2891038 3446758 020199-005 032900-012 061801-002 111599-009 2891189 3456156 020199-007 032900-013 061801-003 111599-010 2891190 3473195 020199-008 032900-014 061801-004 111599-011 2973043 3473196 020199-009 032900-015 061801-005 11599-013 2973044 3473198 020199-012 032900-016 062601-006 120700-001 2973045 3473201 020199-020 032900-017 062601-007 120700-002 2973046 3473206 020199-026 032900-018 062601-008 120700-003 2973047 3492930 020402-029 032900-019 062601-009 120700-004 3025916 3527773 020402-030 032900-020 062601-010 120700-005 3025917 3527774 020402-27 032900-021 070501-001 120700-006 3025918 3527775 021102-002 032900-027 070501-002 120700-007 3025920 3527776 031299-003 032900-028 070501-003 120700-008 3025921 3527777 031299-004 032900-029 070501-004 120700-009 120700-010 121198-002 121198-003 2787163 3188652 010702-006 050101-004 062700-014 092601-003 102502-017 2787165 3188653 010803-001 050101-005 062700-015 092701-002 102502-018 2787166 3295983 021302-001 060502-001 072501-001 092701-003 103001-001 2787167 3295988 021302-002 060502-002 072501-002 092701-004 103001-002 2787168 3411186 021302-003 060502-003 072501-003 092701-005 103001-003 2891036 3411389 021302-004 060502-004 072501-004 101601-001 103001-004 2891189 3446759 021302-005 060502-005 072501-005 101601-002 103001-005 3019925 3456146 032900-012 060502-006 080502-004 101601-003 110701-001 3019926 3456152 041001-001 060502-007 080502-005 101601-004 110701-002 3188645 3527778 041001-002 060502-008 080502-006 101601-005 110701-003 3188646 3527779 041601-001 060502-009 080502-007 102502-011 121901-001 3188647 3527780 041601-002 060502-010 080502-008 102502-012 121901-002 3188648 010603-008 041601-003 062700-005 090399-007 102502-013 121901-003 3188649 010603-009 050101-001 062700-011 090501-001 102502-014 121901-004 3188650 010603-011 050101-002 062700-012 090501-002 102502-015 121901-005 3188651 010603-012 050101-003 062700-013 090501-004 102502-016
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution
  • 제품 설명
    RF Ablation System Foot Switch, used with the EPT-1000 RF Generator, Foot Switch Model Number UPN M0048400, and in kits with UPNs M0044810 and M0044811. || Intended use: The EPT-1000xp Cardiac Ablation Controllers and Foot Switch are indicated for use in cardiac ablation procedures with standard and high power BSC cardiac ablation Catheters.
  • Manufacturer
    Boston Scientific Corp