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Recall Observatory FDA recall evidence

Device product

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

Z-0079-2022

February 09, 2021

Class II

Product summary

Firm
Philips North America LLC
Event
Event 88637
Status
Ongoing
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-0079-2022

Official wording

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

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

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.