FDAFDA · Food and drugs·Recall number Z-0862-2019
LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LP15 monitor/defibrillator is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
Published March 6, 2019 · Recall initiated: February 1, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no response in keypad and device functions.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Physio-Control Inc
- Distributor
- Worldwide Distribution
- Lot
- Serial Numbers: 38344771 38523396 39370585 39747192 40266966 40284286 40284289 40284297 40758461 40767555 40918431 40991313 40991452 40991700 40991743 40991746 40991996 40995181 40995294 40995323 40995420 40995421 40995508 40995550 40995583 40995613 40995621 40995656 41216405 41216406 41216566 41216581 41216600 41216608 41216617 41216618 41216631 41216632 41216636 41216650 41216655 41216660 41216665 41216668 41216680 41216682 41216736 41216743 41216767 41216795 41216797 41216806 41216822 41216828 41216849 41216851 41216854 41216917 41216925 41216955 41216974 41216980 41217013 41217080 41217083 41217104 41217122 41217123 41217131 41217179 41217214 41217221 41217224 41217225 41217233 41217666 41217667 41217677 41217698 41217715 41217722 41217783 41217785 41217791 41217800 41217802 41217834 41217893 41217894 41217929 41218236 41218625 41218627 41218648 41218684 41218810 41218812 41218821 41218846 41218885 41218891 41218909 41218932 41218935 41218938 41218948 41218949 41218951 41219009 41219014 41220729 41220733 41220743 41220763 41220764 41220773 41220794 41220804 41220845 41220854 41220857 41220861 41220862 41220875 41220877 41220885 41220891 41220894 41220941 41220944 41220998 41221005 41221099 41221104 41221105 41221133 41221254 41221255 41221275 41221305 41221311 41221328 41221364 41221390 41221444 41221446 41221447 41221473 41221483 41221494 41221503 41221536 41221545 41221547 41221554 41221555 41221569 41221597 41221606 41221608 41221613 41221630 41221989 41221999 41222096 41222112 41222119 41222177 41222245 41222355 41222440 41222610 41222661 41222725 41222810 41222838 41222907 41222921 41225022 41225110 41225126 41225245 41225293 41226675 41231145 41235035 41238528 41238550 41238554 41238597 41238692 41238788 41238820 41238835 41238852 41238898 41238946 41238990 41238994 41239071 41239120 41239140 41239141 41239194 41239196 41239200 41239228 41239314 41239324 41239373 41239443 41239460 41239469 41239473 41239563 41239594 41239643 41239661 41239671 41239677 41239734 41239754 41239756 41239812 41239833 41239891 41239912 41239920 41239946 41240005 41241905 41241908 41241921 41241944 41241995 41242019 41242073 41242166 41242262 41242270 41242307 41242321 41242343 41242345 41242351 41242375 41242376 41242401 41242511 41242517 41242605 41242653 41242686 41242707 41242729 41242762 41242809 41242820 41242880 41242912 41242948 41242961 41242998 41243188 41243324 41243368 41243445 41243507 41243530 41243565 41243634 41243696 41243777 41244393 41244442 41244612 41244815 41244943 41245095 41246831 41246858 41246954 41246964 41246972 41246982 41246999 41247278 41247310 41247325 41247494 41247644 41248026 41248884 41250244 41250331 41250348 41250486 41250488 41250552 41250566 41250570 41250608 41251349 41251434 41251893 41251961 41251970 41253186 41253236 41253482 41253541 41253650 41253695 41253718 41253727 41253862 41254102 41254164 41254462 41254484 41254543 41254562 41254628 41254761 41254876 41257159 41257186 41257675 41266920 41266947 41267220 41267244 41267358 41267407 41267578 41267597 41267807 41267857 41267879 41267894 41267914 41267942 41267943 41267986 41268050 41270057 41270060 41270080 41270085 41270095 41270096 41270100 41270127 41270129 41270133 41270137 41270141 41270150 41270158 41270162 41270183 41270192 41270211 41270220 41270248 41270269 41270285 41270301 41270354 41270381 41270385 41270435 41270437 41270501 41270551 41270575 41270822 41270857 41270870 41270891 41270895 41271071 41271473 41271485 41271540 41271634 41271741 41271810 41272155 41272224 41272225 41272258 41272318 41272346 41272474 41274356 41274546 41274673 412
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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