HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A
Medical device recall Z-2842-2016. Published in FDA’s Enforcement Report on Sep 28, 2016.
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 Sep 28, 2016. 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
- 394 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 handle can separate from the MRx housing due to breakage of mounts on the rear case.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A
394 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
US Serial Numbers: US00100227 US00100297 US00100326 US00100337 US00100429 US00100715 US00101184 US00101468 US00101676 US00101690 US00102018 US00203809 US00205745 US00205756 US00206142 US00206498 US00206615 US00206821 US00207095 US00207101…
Every code shown here, 1,345 characters
US Serial Numbers: US00100227 US00100297 US00100326 US00100337 US00100429 US00100715 US00101184 US00101468 US00101676 US00101690 US00102018 US00203809 US00205745 US00205756 US00206142 US00206498 US00206615 US00206821 US00207095 US00207101 US00207144 US00207209 US00207268 US00207295 US00207321 US00207324 US00207345 US00208019 US00208263 US00208431 US00208519 US00210744 US00210966 US00211478 US00211485 US00212939 US00213455 US00213819 US00214103 US00214173 US00214222 US00316387 US00316389 US00316444 US00317530 US00318184 US00318460 US00321017 US00321936 US00323885 US00325280 US00326630 US00327632 US00328050 US00328154 US00328968 US00330028 US00330043 US00330093 US00331414 US00332111 US00534036 US00534522 US00535148 US00535803 US00539517 US00540460 US00541251 US00541256 US00541257 US00541366 US00541627 US00543683 US00543856 US00544956 US00545221 US00545649 US00554157 US00555242 US00571887 US00574441 US00574758 Canada: US00100770 US00101622 US00101811 US00204864 US00204987 US00205107 US00325446 US00325734 US00539650 US00565585 US00569569 ROW: US00101691 US00208635 US00327490 US00101209 US00206875 US00208214 US00209571 US00212610 US00212964 US00100372 US00536445 US00100883 US00207958 US00100861 US00211015 US00100171 US00100628 US00534545 US00321215 US00205732 US00208194 MRx units that have the Old Cap Plate, shipped before 2010.
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, Canada, AUSTRALIA, FRANCE, GERMANY, INDIA, JAPAN, NETHERLANDS, SOUTH AFRICA, SPAIN, SWEDEN, THAILAND, and 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 Aug 26, 2016.
- FDA classified it on Sep 19, 2016.
- FDA’s Enforcement Report published it on Sep 28, 2016.
- FDA terminated it on Jul 24, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips Electronics North America Corporation, 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.”
- 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.