LIFEPAK 1000 defibrillator
Medical device recall Z-1660-2014. Published in FDA’s Enforcement Report on Jun 4, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 4, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 96,611 units total (40,974 in the US and 55,637 outside the US) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.
96,611 units total (40,974 in the US and 55,637 outside the US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,998 characters
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…
FDA’s list runs to 963,170 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 9, 2014.
- FDA classified it on May 23, 2014.
- FDA’s Enforcement Report published it on Jun 4, 2014.
- FDA terminated it on May 29, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Physio-Control, Inc., of Redmond, WA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 963,170 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.