FDAFDA · Food and drugs·Recall number Z-0081-2022
Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
Published October 20, 2021 · Recall initiated: February 9, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Customers were not notified of previous recalls associated with various defibrillator models.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America LLC
- Distributor
- 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.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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