LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended…
Medical device recall Z-0294-2018. Published in FDA’s Enforcement Report on Jan 17, 2018.
- 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 Jan 17, 2018. 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
- 3831 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?
Physio-Control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. The symptoms of these failures may include unexpected power on and power off, device lock-up, or a failure to power on or off, any of which has the potential to result in a failure to deliver therapy to the patient and serious injury or death.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physician s office, and clinic setting by personnel who are authorized by a physician/medical director. It is intended for use on a crash cart as well as for portable emergency response throughout a hospital.
3831 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
45039371 45041785 45044636 45057093 45067882 45073270 45450645 45491315 45491441 45491644 45808476 45813092 45598878 45599806 45073745 45435012 45439562 45278002 45307727 45307732 45307742 45308078 45309308 45309310 45309317 45309923…
Every code shown here, 1,998 characters
45039371 45041785 45044636 45057093 45067882 45073270 45450645 45491315 45491441 45491644 45808476 45813092 45598878 45599806 45073745 45435012 45439562 45278002 45307727 45307732 45307742 45308078 45309308 45309310 45309317 45309923 45310487 45310523 45489720 45321756 45605113 45167375 45160349 45540221 45066559 45551722 45253909 45635361 45313588 45314492 45321757 45173154 45807047 45694119 45041460 45041335 45041572 45486374 45439205 45451242 45468563 45860139 45321722 45399194 45040553 45937962 45860005 45889371 45890053 45890181 45890310 45890600 45168699 45486960 45490591 45802737 45802739 45949393 45874190 45802736 45057137 45173422 45175430 45175496 45257327 44963488 45045796 45045990 45046296 45074231 45247320 45314855 45391419 45445721 45579549 45624977 45625366 45933892 45935769 45935894 45936081 45936175 45936811 45371506 45399258 45584143 45584240 45584531 45591943 45592637 45592826 45604856 45625247 45073272 45111392 45260403 45260814 45274367 45304697 45307492 45308174 45390779 45463390 45464179 45543704 45828889 45166687 45312978 45312991 45313074 45313083 45313100 45313174 45313405 45313592 45313824 45313980 45313993 45314061 45314071 45314134 45314230 45314238 45314356 45314516 45314673 45429741 45430061 45430472 45463404 45464415 45471456 45472539 45476795 45543521 45599919 45604525 45624723 45626387 45635109 45635444 45635762 45636110 45873406 45873427 45873809 45873903 45880717 45880719 45880722 45880775 45880807 45880812 45880817 45880843 45880906 45880909 45880912 45881226 45881832 45881834 45881836 45881837 45882215 45158987 45392115 45392169 45469664 45540364 45540508 45542915 45542972 45543122 45259450 45269320 45430201 45435880 45437503 45437998 45439118 45445967 45446520 45446683 45446933 45451695 45451811 45451974 45457626 45457734 45463253 45463296 45463481 45463510 45516006 45584666 45584880 45625468 45663729 45811955 45866408 45058375 45105056 45166654 45166795 45175743 45175963 45335125 45335281 45335440 45337595 45337680 45337902…
FDA’s list runs to 34,487 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 Dec 4, 2017.
- FDA classified it on Jan 11, 2018.
- FDA’s Enforcement Report published it on Jan 17, 2018.
- FDA terminated it on Apr 1, 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: 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 34,487 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.