FDA-Device2014-06-04Class II
LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.
Physio-Control, Inc.
Hazard
Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. A defibrillator in this scenario has the potential to fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. A software malfunction in the LIFEPAK 100
Sold states
Worldwide Distribution-USA (nationwide) and the countries of ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BARBADOS, BELGIUM, BOLIVIA, BOSNIA AND HERZOGOVENIA, BRAZIL, BRUNEI DARUSSALAM, CANADA, CANARY ISLANDS, CAYMAN ISLANDS, CHILE, China, COLOMBIA, COSTA RICA, CROATIA, Curacao, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, Espa¿a, FAROE ISLANDS, FINLAND, FRANCE, FRENCH GUIANA, FRENCH POLYNESIA, GABON, GEORGIA, GERMANY, GREECE, GUAM, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, ISLAMIC REPUBLIC OF, IRAQ, IRELAND, ISRAEL, ITALY, Japan, JORDAN, KAZAKHSTAN, KENYA, KOREA, REPUBLIC OF, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MACAU, MACEDONIA, THE FORMER YUGOSL, MALAYSIA, MALDIVES, MALTA, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, REUNION, ROMANIA, RUSSIA FEDERATION, SAN MARINO, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, Suriname, South America, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, TURKMENISTAN, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VENEZUELA.
Affected count
96,611 units total (40,974 in the US and 55,637 outside the US)
Manufactured in
11811 Willows Rd Ne, Redmond, WA, United States
Products
LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1660-2014Don't want to check this manually?
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