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GE Healthcare, LLC recalls GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station.
Recalled February 26, 2014 · FDA recall Z-0982-2014 · GE Healthcare
Hazard
GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor and Dash Port 2 Docking Station: DASH: 1. Dash stops communicating on the Unity Network resulting in Loss of Monitoring at the CARESCAPE" CIC Pro Central Station*. 2. Dash displays distorted ECG waveforms in combination monitoring mode. 3. Dash incorrectly becomes Time Master on the Unity Network¿. 4. · FDA Class II
Units
178,711 (92,123 US, 86,588 OUS)
Sold at
Worldwide Distribution: USA (nationwide) including DC and PR; and Internationally to: ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOSNIA-HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CAMEROON, CANDA, CARIBBEAN, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DJIBOUTI, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GABON, GEORGIA, GERMANY, GHANA, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, IVORY COAST, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, MALAYSIA, MALTA, MAURITIUS, MEXICO, MOLDOVIA, MOROCCO, NEPAL, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA MONTENEGRO, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SUDAN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, TAJIKISTAN, TANZANIA, THAILAND, TRINIDAD TOBAGO, TUNISIA, TURKEY, TURKMENISTAN, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM, YEMEN, and ZIMBABWE.
Description
GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor and Dash Port 2 Docking Station: DASH: 1. Dash stops communicating on the Unity Network resulting in Loss of Monitoring at the CARESCAPE" CIC Pro Central Station*. 2. Dash displays distorted ECG waveforms in combination monitoring mode. 3. Dash incorrectly becomes Time Master on the Unity Network¿. 4.
Product
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station.
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →