FDA-Device2020-01-22Class II
LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
Physio-Control, Inc.
Hazard
Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button.
Sold states
Worldwide Distribution - U.S Nationwide: GA, PA, IN, CA, KY, FL, AZ, WA, NC, MD, TX, CO, VT, MI, MA, TN, OH, CT, NY, MO, VA, IA, MN, LA, WV, MT, IL, AR, UT, NJ, OK, NV, NH, MS, NM, WI, OR, ID, SC, NE, AK, SD, AL, WY, RI, KS, ME, DE, ND, DC, HI, PR O.U.S. (Foreign): Germany, Netherlands, Hong Kong, Costa Rica, Canada, Singapore, Australia, France, Croatia, Italy , Sweden, Hungary,United Arab Emirates, Qatar, Ireland, Greece, Spain, Poland, Saudi Arabia, Reunion, Israel, United Kingdom, Mexico, South Africa, China, Switzerland, Denmark, Cayman Islands, Finland, Norway, Austria, Japan, Belgium, Czech Republic, New Zealand, Slovenia, Republic of Korea, Oman, Egypt, French Guiana, Iceland, Portugal, Latvia, Lebanon, Chile, Kuwait, Bosnia and Herzegovina, Yemen, Eritrea, Martinique, New Caledonia, Kenya, Romania, Guinea, Luxembourg, Kazakhstan, Papua New Guinea, Brazil, Venezuela, Bolivarian Republic of, Trinidad and Tobago, Algeria, Turkey, Ukraine, Bahrain, Congo, the Democratic Republic of the, Nigeria, Lao People's Democratic Republic, Russian Federation, Cyprus, Pakistan, Faroe Islands, Gabon,Libya, Thailand, Indonesia, Lithuania, Georgia, Malta, Macedonia, the former Yugoslav Republic of, Suriname, San Marino, Morocco, Guam, Taiwan, Province of China, Malaysia,Serbia, Brunei Darussalam, Argentina, Virgin Islands, U.S., Barbados, Mali, Iraq, Azerbaijan, Botswana, Kosovo, Cambodia, Cura¿ao, Ecuador, Aruba
Affected count
705
Manufactured in
11811 Willows Rd Ne, Redmond, WA, United States
Products
LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0817-2020Don't want to check this manually?
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