Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED
Medical device recall Z-1272-2020. Published in FDA’s Enforcement Report on Feb 26, 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 Feb 26, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 13 states named in where it went
- Total 96 units = 95 units (HS1 Onsite) and 1 unit (HS1 Home) 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?
Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
Total 96 units = 95 units (HS1 Onsite) and 1 unit (HS1 Home), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
HeartSmart HS1 Onsite Model: M5066A Software Version: FRx codeRev: E.03.063 System Serial Numbers: A18B-01564 A18B-05110 A15F-00203 A15F-00836 A16A-05193 A18B-01898 A18B-04580 A18C-06368 A18C-13087 A14J-05349 A17G-04454 A16F-05540…
Every code shown here, 1,154 characters
HeartSmart HS1 Onsite Model: M5066A Software Version: FRx codeRev: E.03.063 System Serial Numbers: A18B-01564 A18B-05110 A15F-00203 A15F-00836 A16A-05193 A18B-01898 A18B-04580 A18C-06368 A18C-13087 A14J-05349 A17G-04454 A16F-05540 A16H-00179 A16I-05335 A15C-06311 A18B-01163 A14E-01309 A14H-00385 A14H-03858 A14J-06953 A15B-02135 A15I-00313 A15J-02119 A15J-03499 A16A-00020 A16A-04110 A16D-02839 A16E-00092 A16E-00321 A16E-01139 A16H-01715 A16H-03269 A16H-03289 A16H-03295 A16H-03388 A16I-01108 A16I-01192 A16J-03827 A16K-09220 A16K-09284 A16K-09350 A16L-08039 A17D-02967 A17E-06623 A17L-05540 A18B-06555 A16B-01360 A16J-04476 A16F-05541 A16K-06215 A17F-05535 A17G-01106 A18B-05091 A16L-03891 A18D-00634 A14I-05831 A14I-06556 A14J-04548 A15H-01226 A15H-04421 A16B-05332 A16E-01367 A16F-01716 A16H-01397 A16H-02511 A16I-01557 A16I-01570 A16I-01572 A16I-01819 A16I-01992 A16I-02579 A16I-03774 A16I-08781 A16I-09247 A16I-09253 A16I-09345 A16K-02763 A17F-01602 A17F-02212 A17F-07151 A17I-06611 A17K-05176 A17L-12513 A17L-13149 A17L-13954 A17L-14968 A18A-00046 A18B-12050 A18C-12844 A18C-13301 A18C-13490 A18C-15686 A18C-16215 A18C-16221 A18C-16224 A18C-16236
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.
HeartStart FRx: US - CA, CT, FL, IL, MO, NY,TN, TX and WI OUS - Australia, Brazil, Canada, Germany, Italy, Japan, South Korea, Norway, Switzerland and Taiwan. HeartStart HS1: US - CT, FL, IL, MI, MS, NJ, TN, TX, WA and WI OUS - Argentina, Australia, Canada, France, Germany, Hong Kong, Italy, Japan, Netherlands, Norway, Spain, Sweden, and Taiwan
The states and territories these words name
13 states and territories.
Every one of them
- California
- Connecticut
- Florida
- Illinois
- Michigan
- Missouri
- Mississippi
- New Jersey
- New York
- Tennessee
- Texas
- Washington
- Wisconsin
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Sep 10, 2019.
- FDA classified it on Feb 19, 2020.
- FDA’s Enforcement Report published it on Feb 26, 2020.
- FDA terminated it on Apr 29, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips North America LLC, 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.”
- 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.