Philips HeartStart FR3 Defibrillator
Medical device recall Z-0175-2019. Published in FDA’s Enforcement Report on Oct 24, 2018.
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 Oct 24, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 11 states named
- 432 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?
Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable pads applied to potential victims of SCA with the following symptoms: 1) Unresponsiveness 2) Absence of normal breathing The HeartStart FR3 is intended for adults and children over 55 pounds (25kg) or 8 years old. Both models 861388 and 861389 are also intended for children under 55 pounds (25kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child s age or weight, do not delay treatment. Device not sterile and not implantable.
432, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers of affected AEDs begin with C16J, C16K, C17A, or C17B. Serial Numbers: C17B-00171 C17A-01227 C17A-01349 C17A-01361 C17B-00322 C17B-00323 C17B-00360 C17B-00172 C16K-01024 C17A-01356 C17A-01382 C17B-00038 C17A-01152 C16K-00726…
Every code shown here, 2,000 characters
Serial Numbers of affected AEDs begin with C16J, C16K, C17A, or C17B. Serial Numbers: C17B-00171 C17A-01227 C17A-01349 C17A-01361 C17B-00322 C17B-00323 C17B-00360 C17B-00172 C16K-01024 C17A-01356 C17A-01382 C17B-00038 C17A-01152 C16K-00726 C17A-01154 C17B-00101 C17B-00102 C17B-00104 C17B-00105 C17B-00107 C17B-00109 C17B-00110 C17B-00111 C17B-00112 C17B-00113 C17B-00114 C17B-00115 C17B-00116 C17B-00117 C17B-00118 C17B-00119 C17B-00125 C17B-00127 C17B-00132 C17B-00133 C17B-00143 C17B-00145 C17B-00158 C17B-00159 C17B-00160 C17B-00163 C16K-00495 C16K-00952 C16K-01029 C17B-00025 C17B-00057 C17B-00059 C17B-00069 C17B-00070 C17B-00071 C17B-00074 C17B-00077 C17B-00082 C17B-00083 C17B-00084 C17B-00089 C17B-00090 C17B-00098 C17B-00173 C17B-00178 C17B-00324 C17B-00120 C17B-00122 C17B-00123 C17B-00124 C17B-00126 C17B-00128 C17B-00129 C17B-00130 C17B-00131 C17B-00134 C17B-00135 C17B-00136 C17B-00137 C17B-00138 C17B-00139 C17B-00140 C17B-00141 C17B-00149 C17B-00150 C17B-00151 C17B-00152 C17B-00153 C17B-00154 C17B-00155 C17B-00156 C17B-00161 C17B-00167 C17B-00169 C17B-00170 C17B-00174 C17B-00175 C17B-00176 C17B-00177 C17B-00179 C17B-00181 C17B-00183 C17B-00185 C17B-00186 C17B-00188 C17B-00189 C17B-00191 C17B-00192 C17B-00193 C17B-00194 C17B-00195 C17B-00196 C17B-00197 C17B-00198 C17B-00199 C17B-00200 C17B-00201 C17B-00202 C17B-00203 C17B-00204 C17B-00206 C17B-00207 C17B-00209 C17B-00210 C17B-00213 C17B-00215 C17B-00216 C17B-00218 C17B-00219 C17B-00223 C17B-00225 C17B-00226 C17B-00227 C17B-00228 C17B-00229 C17B-00232 C17B-00240 C17B-00243 C17B-00244 C17B-00245 C17B-00246 C17B-00247 C17B-00248 C17B-00255 C17B-00256 C17B-00257 C17B-00258 C17B-00259 C17B-00260 C17B-00261 C17B-00263 C17B-00264 C17B-00265 C17B-00266 C17B-00277 C17B-00278 C17B-00283 C17B-00287 C17A-01261 C17A-01262 C17A-01263 C17A-01265 C17A-01277 C17A-01292 C17A-01293 C17A-01295 C17A-01341 C17A-01343 C17A-01351 C17A-01354 C17A-01355 C17A-01357 C17A-01359 C17A-01360 C17A-01362 C17A-01366 C17A-01368 C17A-01371 C17A-01372…
FDA’s list runs to 4,837 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 - U.S Nationwide in the states of: GA, MO, IN, FL, NY, HI, CA, LA, WA, IL, NE; Foreign (OUS):Australia, Austria,Belgium, Canada, France, Germany, Hong Kong, Italy, Japan, Kazakhstan, Netherlands, Norway, Spain, Switzerland, Taiwan, United Kingdom
The states and territories these words name
- California
- Florida
- Georgia
- Hawaii
- Illinois
- Indiana
- Louisiana
- Missouri
- Nebraska
- New York
- Washington
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 Oct 10, 2018.
- FDA classified it on Oct 17, 2018.
- FDA’s Enforcement Report published it on Oct 24, 2018.
- FDA terminated it on Aug 19, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips Electronics North America Corp., of Bothell, 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 4,837 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.