Device product
Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A
Z-0080-2022
Product summary
- Event
- Event 88637
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9 units
- Official record key
device-enforcement:Z-0080-2022
Official wording
Reason: Customers were not notified of previous recalls associated with various defibrillator models.
Code information: Affected serial numbers for Model # 5068A: A10A-01936, A09J-02570, A04L-01521, A10H-04433, A09J-01944, A07H-03121, A08A-03450, A08A-05842, 1007257517
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.