Device product
Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304
Z-0079-2022
Product summary
- Event
- Event 88637
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6 units
- Official record key
device-enforcement:Z-0079-2022
Official wording
Reason: Customers were not notified of previous recalls associated with various defibrillator models.
Code information: Model 861304 serial number: 0805164058, B12C-03067, B07I-01107, B09D-01464, B08L-00595, B10I-03918
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.