Philips HeartStart MRx Monitor/Defibrillators
Medical device recall Z-2157-2020. Published in FDA’s Enforcement Report on Jun 3, 2020.
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 3, 2020. 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
- 260 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?
HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation.
260 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: US00100834 US00568320 US00101892 US00102393 US00206641 US00330166 US00207698 US00101198 US00602579 US00002011 US00101199 US00102000 US00102001 US00206119 US00206643 US00206812 US00206843 US00207050 US00210171 US00210937…
Every code shown here, 1,996 characters
Serial Numbers: US00100834 US00568320 US00101892 US00102393 US00206641 US00330166 US00207698 US00101198 US00602579 US00002011 US00101199 US00102000 US00102001 US00206119 US00206643 US00206812 US00206843 US00207050 US00210171 US00210937 US00210939 US00211096 US00211098 US00212132 US00212133 US00212134 US00213504 US00213507 US00317103 US00322662 US00327284 US00327290 US00327294 US00327796 US00327799 US00500001 US00534511 US00534512 US00534513 US00534514 US00535445 US00536360 US00536361 US00539849 US00539850 US00539851 US00539852 US00540841 US00545611 US00546914 US00546915 US00549033 US00549394 US00549396 US00549397 US00550766 US00550767 US00550768 US00550769 US00550770 US00550771 US00550966 US00551296 US00552735 US00553511 US00553520 US00553909 US00556154 US00556155 US00556380 US00556381 US00556382 US00556384 US00556385 US00556386 US00556388 US00556389 US00556390 US00556391 US00556392 US00556393 US00556394 US00561199 US00561200 US00565044 US00565045 US00565046 US00565047 US00565048 US00565049 US00565050 US00565051 US00565052 US00565053 US00565054 US00565055 US00565056 US00565057 US00565058 US00565779 US00565780 US00565781 US00565782 US00565783 US00565784 US00565785 US00565786 US00565787 US00565788 US00565789 US00565790 US00565791 US00565793 US00565794 US00565795 US00565796 US00565798 US00565870 US00565944 US00566589 US00566711 US00568428 US00568429 US00568430 US00569909 US00569910 US00570053 US00570054 US00570745 US00570746 US00570747 US00570748 US00570749 US00570750 US00570751 US00570752 US00573083 US00573979 US00573980 US00574104 US00574105 US00574106 US00574107 US00574109 US00574110 US00574111 US00574113 US00574114 US00574115 US00574116 US00574117 US00574118 US00574409 US00576870 US00576871 US00576872 US00576873 US00576876 US00576877 US00578292 US00578293 US00578294 US00578295 US00578296 US00578353 US00578354 US00578356 US00578357 US00578359 US00578360 US00578361 US00578363 US00578364 US00578365 US00578366 US00578367 US00578369 US00578370 US00578371 US00578373…
FDA’s list runs to 2,875 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 - US Nationwide distribution and the countries of China, Republic of Korea, Netherlands, Norway, United Kingdom.
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 Apr 27, 2020.
- FDA classified it on May 28, 2020.
- FDA’s Enforcement Report published it on Jun 3, 2020.
- FDA terminated it on Jul 19, 2021.
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 2,875 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.