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Recall Observatory FDA recall evidence

Device product

Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A

Z-0081-2022

February 09, 2021

Class II

Product summary

Firm
Philips North America LLC
Event
Event 88637
Status
Ongoing
Classification
Class II
Quantity
15 units
Official record key
device-enforcement:Z-0081-2022

Official wording

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

Code information: 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.

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.