FDA recall Z-0118-2023

Product

AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR

Reason for recall

Due to increase in Li-Ion Battery failures

Distribution

U.S.: AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, RN, TX, UT, VA, VT, Virgin Islands, WA, WI, WV and WY. O.U.S.: United Arab Emirates, Austria, Australia, Azerbaijan, Brazil, Belarus, Canada, Switzerland, China, Costa Rica, Germany, Denmark, Egypt, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Israel, India, Iraq, Italy, Jordan, Japan, South Korea, Moldova, Mexico, Malaysia, Netherlands, Norway, Panama, Philippines, Poland, Qatar, Romania, Russian, Saudi Arabia, Singapore, Slovenia, Taiwan, and Vietnam.

Key facts

Status

Ongoing

Initiation date

2022-09-22

Report date

2022-11-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Jose, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0118-2023