LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete…
Medical device recall Z-0862-2019. 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
- 13,005 units 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 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.
13,005 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,996 characters
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…
FDA’s list runs to 126,809 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 126,809 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
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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.