LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
Medical device recall Z-0817-2020. Published in FDA’s Enforcement Report on Jan 22, 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 Jan 22, 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 52 states named
- 705 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?
Monitor/Defibrillator may not deliver a shock after the “Shock” button on the keypad is pressed as a result of oxidation that has formed over time within the button.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
705, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial numbers: 39432283 39432694 39432696 39432697 39432698 39432699 39432700 39432701 39432702 39432719 39432854 39432855 39432856 39432857 39432858 39432859 39432860 39432862 39432863 39432864 39432865 39432866 39432867 39432868…
Every code shown here, 1,996 characters
Serial numbers: 39432283 39432694 39432696 39432697 39432698 39432699 39432700 39432701 39432702 39432719 39432854 39432855 39432856 39432857 39432858 39432859 39432860 39432862 39432863 39432864 39432865 39432866 39432867 39432868 39432869 39432870 39432871 39432872 39432873 39432874 39432875 39432876 39432877 39432878 39432879 39432881 39432882 39432883 39432884 39432885 39432887 39432888 39432889 39432890 39432893 39432896 39432897 39432898 39432899 39432900 39432901 39435315 39436589 39451160 39451161 39451164 39451165 39451166 39451167 39451168 39451169 39451170 39451172 39451174 39451175 39451180 39451181 39451182 39451183 39451184 39451185 39451186 39451187 39451188 39451189 39451190 39451191 39451192 39451193 39451196 39451197 39451198 39451199 39451200 39451201 39451202 39451204 39451205 39451206 39451207 39451208 39451209 39451210 39451212 39451213 39451214 39451215 39451216 39451217 39451218 39451219 39451220 39451221 39451222 39451223 39451224 39451225 39451226 39451227 39451228 39451229 39451230 39451232 39451233 39451234 39451235 39451236 39451237 39451238 39451239 39451240 39451241 39451242 39451247 39451248 39451249 39451250 39451251 39451253 39451254 39451255 39452420 39452421 39452422 39452423 39452424 39452431 39452432 39452433 39452434 39452435 39452436 39452437 39452438 39452439 39452440 39452441 39452442 39452444 39452445 39452446 39454151 39454152 39454153 39454154 39454155 39454156 39454157 39454158 39454160 39454161 39454162 39454163 39454164 39454165 39454166 39454167 39454168 39454169 39454171 39454172 39454173 39454174 39454175 39454176 39454177 39454178 39454179 39454180 39454181 39454182 39454183 39454184 39454185 39454186 39454187 39454188 39454189 39454190 39454191 39454192 39454193 39454194 39454195 39454196 39454197 39454198 39454199 39454200 39454201 39454202 39454203 39454204 39454205 39454206 39454207 39454208 39454209 39454210 39454212 39454213 39454223 39454224 39454225 39454226 39454232 39454233 39454234 39454235 39454236…
FDA’s list runs to 6,360 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: GA, PA, IN, CA, KY, FL, AZ, WA, NC, MD, TX, CO, VT, MI, MA, TN, OH, CT, NY, MO, VA, IA, MN, LA, WV, MT, IL, AR, UT, NJ, OK, NV, NH, MS, NM, WI, OR, ID, SC, NE, AK, SD, AL, WY, RI, KS, ME, DE, ND, DC, HI, PR O.U.S. (Foreign): Germany, Netherlands, Hong Kong, Costa Rica, Canada, Singapore, Australia, France, Croatia, Italy , Sweden, Hungary,United Arab Emirates, Qatar, Ireland, Greece, Spain, Poland, Saudi Arabia, Reunion, Israel, United Kingdom, Mexico, South Africa, China, Switzerland, Denmark, Cayman Islands, Finland, Norway, Austria, Japan, Belgium, Czech Republic, New Zealand, Slovenia, Republic of Korea, Oman, Egypt, French Guiana, Iceland, Portugal, Latvia, Lebanon, Chile, Kuwait, Bosnia and Herzegovina, Yemen, Eritrea, Martinique, New Caledonia, Kenya, Romania, Guinea, Luxembourg, Kazakhstan, Papua New Guinea, Brazil, Venezuela, Bolivarian Republic of, Trinidad and Tobago, Algeria, Turkey, Ukraine, Bahrain, Congo, the Democratic Republic of the, Nigeria, Lao People’s Democratic Republic, Russian Federation, Cyprus, Pakistan, Faroe Islands, Gabon,Libya, Thailand, Indonesia, Lithuania, Georgia, Malta, Macedonia, the former Yugoslav Republic of, Suriname, San Marino, Morocco, Guam, Taiwan, Province of China, Malaysia,Serbia, Brunei Darussalam, Argentina, Virgin Islands, U.S., Barbados, Mali, Iraq, Azerbaijan, Botswana, Kosovo, Cambodia, Cura¿ao, Ecuador, Aruba
The states and territories these words name
52 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
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 Dec 20, 2019.
- FDA classified it on Jan 16, 2020.
- FDA’s Enforcement Report published it on Jan 22, 2020.
- FDA terminated it on Oct 4, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Physio-Control, Inc., of Redmond, 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 6,360 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.