FDA recall Z-0079-2022

Philips North America LLC · Class II · device

Product

Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304

Reason for recall

Customers were not notified of previous recalls associated with various defibrillator models.

Distribution

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.

Key facts

Status: Ongoing
Initiation date: 2021-02-09
Report date: 2021-10-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bothell, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0079-2022