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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Philips North America LLC: Customers were not notified of previous recalls associated with various defibrillator models.

Agency Publication Date: October 8, 2021
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Affected Products

Product: Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304

Model 861304 serial number: 0805164058, B12C-03067, B07I-01107, B09D-01464, B08L-00595, B10I-03918

Product: 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

Product: 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

Product: 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.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88637
Status: Active
Manufacturer: Philips North America LLC
Manufactured In: United States
Units Affected: 4 products (4 units; 6 units; 9 units; 15 units)
Agency Last Updated: November 23, 2021

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.