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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0816-2020

LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad.

Publicado el 22 de enero de 2020 · Inicio del retiro: 20 de diciembre de 2019

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

Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Physio-Control, Inc.
Distribuidor
Worldwide Distribution - U.S Nationwide: GA, PA, IN, CA, KY, FL, AZ, WA, NC, MD, TX, CO, VT, MI, MA, TN, OH, CT, NY, MO, VA, IA, MN, LA, WV, MT, IL, AR, UT, NJ, OK, NV, NH, MS, NM, WI, OR, ID, SC, NE, AK, SD, AL, WY, RI, KS, ME, DE, ND, DC, HI, PR O.U.S. (Foreign): Germany, Netherlands, Hong Kong, Costa Rica, Canada, Singapore, Australia, France, Croatia, Italy , Sweden, Hungary,United Arab Emirates, Qatar, Ireland, Greece, Spain, Poland, Saudi Arabia, Reunion, Israel, United Kingdom, Mexico, South Africa, China, Switzerland, Denmark, Cayman Islands, Finland, Norway, Austria, Japan, Belgium, Czech Republic, New Zealand, Slovenia, Republic of Korea, Oman, Egypt, French Guiana, Iceland, Portugal, Latvia, Lebanon, Chile, Kuwait, Bosnia and Herzegovina, Yemen, Eritrea, Martinique, New Caledonia, Kenya, Romania, Guinea, Luxembourg, Kazakhstan, Papua New Guinea, Brazil, Venezuela, Bolivarian Republic of, Trinidad and Tobago, Algeria, Turkey, Ukraine, Bahrain, Congo, the Democratic Republic of the, Nigeria, Lao People's Democratic Republic, Russian Federation, Cyprus, Pakistan, Faroe Islands, Gabon,Libya, Thailand, Indonesia, Lithuania, Georgia, Malta, Macedonia, the former Yugoslav Republic of, Suriname, San Marino, Morocco, Guam, Taiwan, Province of China, Malaysia,Serbia, Brunei Darussalam, Argentina, Virgin Islands, U.S., Barbados, Mali, Iraq, Azerbaijan, Botswana, Kosovo, Cambodia, Cura¿ao, Ecuador, Aruba
Lote
Serial numbers: 37964613 37964617 37964621 37964628 37964630 37968424 37968429 37964596 37964601 37964607 37964610 37968715 37968716 37968717 37968718 37968721 37968722 37968724 38046540 38046549 38046552 38046565 38046571 38046572 38046573 38051949 38051951 38051954 38051955 38051958 38051963 38051969 38051972 38051973 38051974 38051980 38053216 38053218 38053220 38053221 38053225 38053231 38053233 38053236 38053239 38059568 38059570 38059574 38059591 38120769 38120772 38120775 38120780 38120781 38120783 38120784 38120787 38120788 38120790 38124016 38124030 38124035 38124042 38124044 38124047 38125969 38125971 38125972 38125980 38125982 38125987 38125990 38126255 38126258 38126260 38126265 38126267 38126269 38126272 38126273 38126277 38127130 38127131 38127132 38127134 38127136 38127138 38127139 38127140 38127141 38127143 38127144 38130272 38130273 38130276 38130277 38130279 38130282 38130283 38130285 38130286 38130287 38131588 38131589 38131592 38131597 38131600 38131602 38131603 38131605 38131607 38131608 38131756 38131757 38131760 38131761 38131762 38131764 38131765 38131767 38131773 38131775 38131776 38131777 38131842 38131845 38132370 38132951 38134512 38134524 38135205 38135212 38135215 38136507 38136508 38136513 38136516 38137137 38137143 38137149 38137155 38137168 38137174 38138844 38138846 38141005 38142743 38150694 38151893 38151898 38153123 38153124 38153136 38155919 38158080 38159137 38159181 38159183 38159187 38159197 38161892 38161893 38161898 38161899 38161902 38161907 38161909 38161912 38162531 38162561 38162597 38164391 38164403 38164420 38164448 38166449 38166461 38166462 38166475 38166479 38166485 38166486 38166497 38166507 38166513 38166516 38166541 38166542 38166543 38166544 38166549 38166550 38166555 38166558 38166569 38166571 38166581 38166582 38166586 38166594 38166610 38166614 38166628 38166632 38166634 38166642 38166647 38166674 38166675 38166676 38166677 38166678 38177270 38177272 38177275 38191219 38191235 38200435 38200436 38200441 38200443 38200444 38200446 38200447 38200448 38200450 38200451 38200452 38200453 38200454 38200457 38200458 38200461 38200462 38200464 38200465 38200466 38200467 38200469 38200470 38200471 38200472 38200474 38200476 38202790 38202791 38202802 38202803 38202809 38202821 38205398 38205404 38205407 38205410 38205413 38205781 38205783 38205784 38205794 38206256 38211038 38211041 38211042 38211043 38211044 38211051 38211059 38214239 38214242 38214247 38214259 38214266 38214271 38214279 38217387 38217390 38217400 38221456 38221457 38224395 38224601 38227461 38253472 38253478 38253768 38253769 38253770 38253786 38253790 38253798 38253805 38263304 38263329 38272217 38273859 38274178 38274396 38274508 38279197 38279198 38279199 38279202 38279206 38281774 38282979 38282983 38282987 38287524 38287525 38287530 38287845 38287846 38290137 38290140 38290141 38290535 38290536 38290538 38290539 38307505 38315311 38315330 38322516 38323219 38323233 38323263 38323311 38324196 38324198 38324199 38324201 38324210 38324213 38327183 38332345 38332349 38332355 38332358 38332363 38332748 38332749 38332753 38332754 38332761 38332940 38338635 38340566 38341984 38343138 38343162 38343235 38343241 38345048 38346560 38353024 38353025 38353033 38354810 38355627 38355629 38355631 38355637 38355638 38355639 38355645 38359027 38359559 38362860 38364966 38365244 38365249 38365937 38365940 38368303 38368304 38368307 38368327 38368329 38368616 38369586 38370274 38370275 38370277 38370280 38370282 38370293 38370425 38370431 38370433 38370434 38371200 38371201 38371218 38371701 38371702 38371708 38371709 38371711 383
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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