Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC,…
Medical device recall Z-1923-2019. Published in FDA’s Enforcement Report on Jul 17, 2019.
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 Jul 17, 2019. 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
- 97,794 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 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?
The AC power module may fail at a higher than expected rate. If a fully charged battery is not properly installed, the HeartStart MRx may lose all power and fail to operate. Interruption of monitoring and failure or delay in the delivery of a shock or pacing can occur. A faulty AC Power Module may also fail to charge the battery.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
97,794 Units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial numbers: US00321116 US00205647 US00205648 US00554104 US00554105 US00554106 US00559530 US00559531 US00559532 US00559533 US00559534 US00559535 US00559536 US00559537 US00559538 US00559539 US00321076 US00321222 US00322701 US00544495…
Every code shown here, 1,996 characters
Serial numbers: US00321116 US00205647 US00205648 US00554104 US00554105 US00554106 US00559530 US00559531 US00559532 US00559533 US00559534 US00559535 US00559536 US00559537 US00559538 US00559539 US00321076 US00321222 US00322701 US00544495 US00320900 US00580288 US00580298 US00580334 US00580335 US00580336 US00580337 US00580338 US00582916 US00582917 US00582918 US00582919 US00582920 US00582921 US00582922 US00582923 US00582924 US00582925 US00582926 US00582927 US00582928 US00582929 US00582930 US00582931 US00582932 US00582933 US00582934 US00582935 US00582936 US00582937 US00582938 US00582939 US00582940 US00582941 US00582942 US00582943 US00582944 US00582945 US00582946 US00582947 US00582948 US00582949 US00582950 US00582951 US00582952 US00582953 US00582954 US00582955 US00582956 US00582957 US00582958 US00582959 US00582960 US00582961 US00582962 US00582963 US00582964 US00582965 US00582966 US00582967 US00582968 US00582969 US00582970 US00582971 US00582972 US00582973 US00582974 US00582975 US00585293 US00585294 US00585295 US00585296 US00585297 US00585298 US00585299 US00585300 US00585301 US00585304 US00585305 US00585306 US00585307 US00585308 US00585309 US00586483 US00586484 US00586485 US00586486 US00586487 US00586488 US00586489 US00586490 US00586491 US00586492 US00589735 US00595040 US00600754 US00600755 US00600756 US00600757 US00600758 US00600759 US00600760 US00600761 US00600762 US00600763 US00600764 US00600765 US00600766 US00600767 US00600768 US00600770 US00600771 US00600772 US00600773 US00600774 US00600775 US00600776 US00600777 US00600778 US00600779 US00600780 US00600781 US00600782 US00600783 US00600784 US00600807 US00600808 US00600809 US00600810 US00600811 US00600812 US00600813 US00600814 US00600815 US00600816 US00600817 US00600818 US00600819 US00600820 US00600821 US00600822 US00600823 US00600824 US00600825 US00600826 US00600844 US00600845 US00600846 US00600847 US00600848 US00600849 US00600850 US00600851 US00600852 US00600853 US00600854 US00600855 US00600856 US00600857 US00600858…
FDA’s list runs to 1,170,854 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.
Nationwide domestic distribution. Worldwide distribution.
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 Jun 7, 2019.
- FDA classified it on Jul 5, 2019.
- FDA’s Enforcement Report published it on Jul 17, 2019.
- FDA terminated it on May 8, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips North America, LLC, of Andover, MA.
- 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 1,170,854 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.