Device product
Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
Z-0078-2022
Product summary
- 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
Customers were not notified of previous recalls associated with various defibrillator models.