LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15)…
Medical device recall Z-0863-2019. Published in FDA’s Enforcement Report on Mar 6, 2019.
- FDA Class I
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 Mar 6, 2019. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 682 kits 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 I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
LIFEPAK 15 Monitor/Defibrillator service kits 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.
682 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 45902644 46103169 45987054 45953396 45483757 45477666 43251338 43251330 43251337 43251331 43251332 43258935 43258939 43258937 43228302 43228304 43228306 43232897 43233020 43232896 43232894 43247620 42916265 42806505…
Every code shown here, 1,996 characters
Serial Numbers: 45902644 46103169 45987054 45953396 45483757 45477666 43251338 43251330 43251337 43251331 43251332 43258935 43258939 43258937 43228302 43228304 43228306 43232897 43233020 43232896 43232894 43247620 42916265 42806505 42798882 42798883 42798884 42792295 42798879 42792292 42792293 42792290 42769668 42769682 42769669 42769683 42769623 42769622 42769667 42682340 42682365 41927593 41927587 41927584 41927586 41927588 41927590 41917524 41909860 41909864 41909859 41917523 41909862 41917526 41909861 41909863 41704060 41675566 41675569 41675568 41675572 41675581 41675579 41664085 41664089 41659957 41280566 41280565 41271940 47605976 47605977 47605978 47605975 47452142 47154005 47153982 47154010 46713840 46713846 46650660 46549016 46549030 46383960 46185756 46185751 45709172 45274780 45084606 44910255 44898379 44825194 44825193 44778785 44778791 44778818 44778776 44534650 44483720 44186841 43817113 43817111 43562342 43562343 43562345 43562346 43294428 42977696 42977695 42721264 42718022 42716902 42585562 42192344 42181588 42037078 41808342 41798093 41436941 41279198 41279196 41279194 41279201 41279200 41278553 41278558 43985820 43964361 43314021 41271935 41271936 41271937 41271941 41271942 41271944 41271907 41271908 41271909 41271910 41271911 41271932 41271933 41271934 41271943 41271945 41271946 41271947 41271948 41271949 41271950 41271951 41691849 42962645 42962646 42962647 42962648 42962649 42962650 42962651 42962652 42962653 42962654 42962655 42962656 42962657 42962658 42962659 42962660 42962661 42962662 42948662 42408699 42408701 41895713 41899580 41899578 41899587 41899585 41899577 41899584 41899588 41899590 41899586 46103178 47741818 47741813 47708269 47708267 47708260 47671993 47688865 47631561 47671990 47501262 47452144 47501258 47501257 47520440 47520425 47520428 47520429 47520424 47485162 47485156 47485160 47485158 47485159 47458556 47458557 47452147 47452146 47421810 47385314 47421827 47421824 47421845 47367598 47225159 47225156 47325491 47325384…
FDA’s list runs to 6,153 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
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Feb 1, 2019.
- FDA classified it on Feb 26, 2019.
- FDA’s Enforcement Report published it on Mar 6, 2019.
- FDA terminated it on Apr 18, 2024.
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: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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 6,153 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.