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Recall Observatory FDA recall evidence

Device product

Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A

Z-0080-2022

February 09, 2021

Class II

Product summary

Firm
Philips North America LLC
Event
Event 88637
Status
Ongoing
Classification
Class II
Quantity
9 units
Official record key
device-enforcement:Z-0080-2022

Official wording

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

Code information: Affected serial numbers for Model # 5068A: A10A-01936, A09J-02570, A04L-01521, A10H-04433, A09J-01944, A07H-03121, A08A-03450, A08A-05842, 1007257517

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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