Philips HeartStart XL Monitor/Defibrillators
Medical device recall Z-2137-2020. 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, and 4 states named
- 130 units (US 126; OUS 4) 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 XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation
130 units (US 126; OUS 4), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: US00127349 US00127341 US00127347 US00127355 US00127357 US00127346 US00126134 US00126145 US00126129 US00126130 US00126131 US00126132 US00126133 US00126135 US00126136 US00126137 US00126141 US00126142 US00126144 US00126146…
Every code shown here, 1,445 characters
Serial Numbers: US00127349 US00127341 US00127347 US00127355 US00127357 US00127346 US00126134 US00126145 US00126129 US00126130 US00126131 US00126132 US00126133 US00126135 US00126136 US00126137 US00126141 US00126142 US00126144 US00126146 US00126147 US00126148 US00126168 US00126169 US00126171 US00126172 US00126173 US00126174 US00126175 US00126176 US00126177 US00126179 US00126180 US00126181 US00126182 US00126183 US00126184 US00126185 US00126186 US00126187 US00127365 US00127345 US00127353 US00127362 US00127364 US00124799 US00124800 US00126138 US00126139 US00126140 US00126143 US00126380 US00126381 US00126382 US00126383 US00127371 US00127372 US00127318 US00127334 US00127335 US00127336 US00127337 US00127338 US00127339 US00127340 US00127342 US00127343 US00127344 US00127348 US00127350 US00127351 US00127354 US00127356 US00127358 US00127359 US00127360 US00127361 US00127363 US00127366 US00127367 US00127368 US00127369 US00127370 US00128359 US00128411 US00230152 US00230153 US00230154 US00230155 US00230156 US00230157 US00128692 US00230709 US00232426 US00574878 US00575747 US00575748 US00575749 US00575750 US00575751 US00582246 US00582247 US00582248 US00582249 US00582250 US00589872 US00593616 US00593617 US00593618 US00593619 US00595090 US00595421 US00595424 US00595425 US00602424 US00602425 US00602426 US00602427 US00602428 US00602429 US00602430 US00126170 US00126178 US00122814 US00127352 US00123379 US00446868 US00579838 US00579839 US00579840
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 including in the states of KY, MA, ND, NY and the countries of United Kingdom, Bahrain.
The states and territories these words name
- Kentucky
- Massachusetts
- North Dakota
- New York
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 21, 2020.
- FDA classified it on May 28, 2020.
- FDA’s Enforcement Report published it on Jun 3, 2020.
- FDA terminated it on Jul 16, 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.”
- 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.