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Recall Observatory FDA recall evidence

Device product

Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A

Z-0078-2022

February 09, 2021

Class II

Product summary

Firm
Philips North America LLC
Event
Event 88637
Status
Ongoing
Classification
Class II
Quantity
4 units
Official record key
device-enforcement:Z-0078-2022

Official wording

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

Code information: Model M3860A affected serial numbers: A09G-04198 and 510800626 Model M3861A affected serial numbers: A09H-00436 and A07J-03514

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.