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Terminated

GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station.

FDA Recall Z-0982-2014 · Posted 2014-02-14

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeMHX
Date Initiated2013-11-27
Date Terminated2016-08-25
Product Quantity178,711 (92,123 US, 86,588 OUS)

Reason for Recall

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.

Firm Action

Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated November 27,2013. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (Contact Technical Support at 1-800-558-7044 or your local Service Representative).

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K073462MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIESGe Medical Systems Information Technologies · 2008-01-11K992929DASH 3000 PATIENT MONITORGeneral Electric Medical Systems Information Techn · 1999-11-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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