Lower risk Medical device recall · FDA · Published February 9, 2021

Philips HeartStart HS1 Defibrillator Recall: Missing Previous Recalls

Philips recalls HeartStart HS1 OnSite Defibrillators (models M5066A/M5067A) due to unreported prior recalls. Affected units have specific serial numbers listed. No immediate action required per recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0081-2022Medical device Philips ›

Lower-risk recall

Customers were not notified of previous recalls associated with various defibrillator models.

Take action

Contact the company

Recalling firmPhilips North America LLC22100 Bothell Everett Hwy · Bothell, WA 98021-8431

✎ GovInfoNow plain-language explainer

Philips is recalling two models of HeartStart HS1 OnSite Defibrillators because customers weren't notified of previous recalls for these devices. This means some users might have already been affected by earlier issues but weren't told. Read more at govinfonow.com/recall/63284-philips-heartstart-hs1-defibrillator-recall-missing-previous-recalls.

Source Summary by GovInfoNow · govinfonow.com/recall/63284-philips-heartstart-hs1-defibrillator-recall-missing-previous-recalls · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0081-2022

Cite this page

“Philips HeartStart HS1 Defibrillator Recall: Missing Previous Recalls.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63284-philips-heartstart-hs1-defibrillator-recall-missing-previous-recalls. Based on FDA recall #Z-0081-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0081-2022%22&limit=1).

The FDA announced on Feb. 9, 2021, that Philips North America LLC is recalling Philips HeartStart HS1 OnSite Defibrillators because customers were not notified of previous recalls associated with various defibrillator models. The agency issued recall number Z-0081-2022 for the Class II voluntary recall.

How to tell if you have it

Brand: Philips
Product: HeartStart HS1 OnSite Defibrillator
Model # M5066A with serial numbers A11K-03264, A07A-01278, B07F-01268, A10G-05443, A06E-00929, A06L-01867, A06L-01678, A07J-05837, A10C-03623, M5066A-ABD, A07K-02685, A09H-03908, 0205142344, A11K-08837
Model # M5067A with serial number A06K-02421

The hazard

According to the FDA, the hazard is that customers were not notified of previous recalls associated with various defibrillator models.

Context

GovInfoNow's records show Philips North America LLC has issued 129 other recalls since July 12, 2017. Recent similar product recalls include the Philips Allura Xper FD10C Medical System Recall on Dec. 15, 2025, and the Boston Scientific LUX-DX II Arrythmia Detector Recall on March 30, 2026.

How to tell if you have this one

Check if your defibrillator has a serial number starting with A06K-02421 for model M5067A or one of the listed serial numbers for model M5066A. The recall covers specific serial numbers provided in the notice.

Brand
Philips
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
U.S.: CA, CT, FL, GA, IN, MI, MO, NJ, NY, OH, TX, and WA. International distribution in the countries of Australia, Canada, France, Germany, Japan, Norway, Switzerland.

Recall number	Product, codes & lots	Quantity
Z-0078-2022	Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A; Model M3860A affected serial numbers: A09G-04198 and 510800626 Model M3861A affected serial numbers: A09H-00436 and A07J-03514	4 units
Z-0079-2022	Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304; Model 861304 serial number: 0805164058, B12C-03067, B07I-01107, B09D-01464, B08L-00595, B10I-03918	6 units
Z-0080-2022	Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A; Affected serial numbers for Model # 5068A: A10A-01936, A09J-02570, A04L-01521, A10H-04433, A09J-01944, A07H-03121, A08A-03450, A08A-05842, 1007257517	9 units
Z-0081-2022	Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A; Affected serial numbers for Model # M5066A: A11K-03264, A07A-01278, B07F-01268, A10G-05443, A06E-00929, A06L-01867, A06L-01678, A07J-05837, A10C-03623, M5066A-ABD, A07K-02685, A09H-03908, 0205142344, Expansion - additional serial numbers for Model # M5066A: A11K-08837, Affected Serial numbers for Model # M5067A: A06K-02421.	15 units

Based on the official FDA remedy

What to do — step by step

Check Serial Numbers
Review your defibrillator's serial number to see if it matches the listed affected numbers for models M5066A or M5067A.

Where it went and when

Where it was distributed

Distributed in 12 states, and outside the U.S.

FDA distribution: “U.S.: CA, CT, FL, GA, IN, MI, MO, NJ, NY, OH, TX, and WA. International distribution in the countries of Australia, Canada, France, Germany, Japan, Norway, Switzerland.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Connecticut, Florida, Georgia, Indiana, Michigan, Missouri, New Jersey, New York, Ohio, Texas, Washington.

Recall timeline

FDA published this recall 8 months after the firm started it.

Feb 9, 2021Firm started the recall
Oct 8, 2021FDA classified it Class II
Oct 20, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/63284-philips-heartstart-hs1-defibrillator-recall-missing-previous-recalls">Philips HeartStart HS1 Defibrillator Recall: Missing Previous Recalls (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0081-2022 (February 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0081-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.