FDAFDA · Food and drugs·Recall number Z-1660-2014
LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.
Published June 4, 2014 · Recall initiated: May 9, 2014
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
Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. A defibrillator in this scenario has the potential to fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. A software malfunction in the LIFEPAK 100
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Physio-Control, Inc.
- Distributor
- Worldwide Distribution-USA (nationwide) and the countries of ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BARBADOS, BELGIUM, BOLIVIA, BOSNIA AND HERZOGOVENIA, BRAZIL, BRUNEI DARUSSALAM, CANADA, CANARY ISLANDS, CAYMAN ISLANDS, CHILE, China, COLOMBIA, COSTA RICA, CROATIA, Curacao, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, Espa¿a, FAROE ISLANDS, FINLAND, FRANCE, FRENCH GUIANA, FRENCH POLYNESIA, GABON, GEORGIA, GERMANY, GREECE, GUAM, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, ISLAMIC REPUBLIC OF, IRAQ, IRELAND, ISRAEL, ITALY, Japan, JORDAN, KAZAKHSTAN, KENYA, KOREA, REPUBLIC OF, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MACAU, MACEDONIA, THE FORMER YUGOSL, MALAYSIA, MALDIVES, MALTA, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, REUNION, ROMANIA, RUSSIA FEDERATION, SAN MARINO, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, Suriname, South America, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, TURKMENISTAN, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VENEZUELA.
- Lot
- Affected Part Numbers: 320371500XXX *****SERIAL NUMBERS FOR US DEPARMENT OF DEFENSE****** 34876034 34876038 34876056 34876064 34876065 34877573 34877574 34877575 34877576 34877578 34877582 34988650 34988651 35122139 35147830 35215123 35215124 35908182 35908183 35972621 35972622 35972623 35972624 35972625 36059654 36065891 36065892 36065893 36065894 36065895 36065896 36065897 36065898 36066291 36066292 36066322 36066323 36066326 36066330 36066331 36066332 36066530 36066569 36066571 36066575 36066676 36085125 36089293 36089294 36089295 36089297 36103234 36103235 36103236 36103237 36103238 36103239 36103240 36103241 36103242 36103243 36103244 36103245 36103246 36103247 36103248 36103249 36103250 36103251 36103252 36103253 36103254 36103255 36103256 36103257 36134589 36145614 36153198 36153199 36153943 36156907 36217327 36217328 36217329 36217330 36217331 36217332 36217333 36217334 36217335 36217336 36217337 36217338 36217339 36217340 36217341 36217342 36217343 36217344 36217345 36217346 36217347 36217348 36217349 36217350 36217351 36217352 36217353 36217354 36217355 36217356 36224665 36224666 36256005 36256006 36256007 36256008 36256009 36256010 36256011 36256012 36256013 36256014 36256016 36256017 36256018 36256019 36256020 36256021 36256022 36256023 36256024 36259851 36380359 36380360 36380361 36380362 36380363 36380364 36380365 36380925 36380926 36381377 36381378 36382666 36383841 36383842 36383843 36383874 36383875 36383876 36383877 36383878 36383879 36383880 36383881 36383882 36384425 36384426 36384805 36384806 36393390 36393391 36393392 36393393 36393394 36393395 36393396 36393397 36393398 36393399 36400169 36403874 36403876 36411149 36411159 36411160 36411163 36411164 36411186 36416177 36416187 36416196 36416199 36416209 36416235 36417721 36425300 36425653 36432930 36448747 36488498 36488499 36488500 36488501 36488502 36488503 36488504 36488506 36488507 36488508 36488509 36488510 36488511 36488512 36488513 36488514 36488515 36488516 36488517 36488518 36488519 36488520 36488521 36488522 36530260 36530261 36530262 36530263 36530264 36530265 36530266 36530267 36530268 36560552 36560553 36560554 36562549 36691688 36691689 36694513 36694536 36694637 36694639 36697212 36698513 36698514 36717710 36728245 36960285 36960286 36964503 36964537 36964538 36964539 36964950 36966460 36970608 36970609 36972424 36974341 36974342 36974965 36986942 36986943 36986944 36986945 36986946 36986947 36986948 36986949 36986950 36986951 36986952 37004183 37004184 37004185 37004186 37004187 37004443 37004444 37004445 37004446 37028054 37063040 37063042 37063043 37063044 37063045 37063046 37063047 37063048 37063049 37063050 37063051 37063052 37063054 37063055 37063056 37064583 37067571 37067572 37067573 37085058 37109482 37109483 37109484 37109485 37119095 37119096 37119097 37119098 37122133 37122134 37123481 37123556 37123790 37123792 37123793 37143088 37165651 37166734 37166735 37192588 37192589 37207187 37207188 37207872 37233621 37233622 37263263 37263264 37263265 37263266 37263267 37263268 37263269 37263270 37263271 37263272 37263273 37263274 37263275 37263276 37263277 37267163 37267164 37267282 37325910 37325968 37326212 37326213 37328690 37337120 37337121 37337122 37337123 37337124 37337125 37337126 37337127 37337128 37337129 37337130 37337131 37337132 37337133 37337134 37337135 37337136 37337137 37337138 37337139 37337140 37337141 37337142 37337143 37337145 37337422 37345127 37345128 37345129 37345130 37345161 37345162 37348599 37349845 37349846 37349847 37349848 37349849 37349850 37349851 37349852 37353967 37353968 37353969 37353970 37353971 37353972 3735
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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