FDA recall Z-1189-2021

Physio-Control, Inc. · Class II · device

Product

PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. After the electrode pads are applied, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any responder assistance. The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest.

Reason for recall

Due to complaints received regarding missing lid magnets which may result in premature battery depletion.

Distribution

Worldwide Distribution to U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI , SC, SD, TN, TX, UT, VA, Virgin Island, VT, WA, WI, WV and WY O.U.S. countries of: Australia, Austria, Belgium, Canada, Chile, Costa Rica, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Luxembourg, Malta, Netherlands, New Zealand, Norway, Poland, Qatar, Saint Barth¿lemy, Singapore, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.

Key facts

Status
Ongoing
Initiation date
2021-01-14
Report date
2021-03-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Redmond, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1189-2021