Device product
Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
Z-0081-2022
Product summary
- 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
Customers were not notified of previous recalls associated with various defibrillator models.