FDAFDA · Food and drugs·Recall number Z-0813-2013
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories.
Published February 20, 2013 · Recall initiated: June 13, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor. These issues may occur when the Ethernet controller in the XPC823 CPU on the Dash and DashPort 2 motherboard functions intermittently. GE Healthcare has identified that these issues occur most often at sites with large Unity Network installations. It should be noted that the Dash 3000/4000/5000 patient m
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- Nationwide Distribution - ALL STATES IN CONTINENTAL USA INCLUDING PR and DC excluding AK, DE, ND, and VT. ALGERIA, AUSTRALIA, ANGOLA, ARGENTINA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELGIUM, BOSNIA HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CUBA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GHANA, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNG ARIA, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAHSTAN, KENYA, KOREA, KUWAIT, LATIVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, MALAYSIA, MEXICO, MALTA, MOROCCO, NEPAL, NETHERLAND, NEW ZEALAND, NIGERIA, NORWAY, PAKISTAN, PALESTINIAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN THAILAND, TRINIDAD AND TOBAGO,K TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARB EMIRATES , UNITED KINGDOM, URUGUAY. PUERTO RICO
- Lot
- FMI# & Descr: 36080 DASH 3/4/5k Custom Auto NBP System ID (As required) SD010210331GA SD010262074GA SD010262088GA SD010272286GA SD010272290GA SD010272298GA SD010272299GA SD010272300GA SD010272304GA SD010272306GA SD010272307GA SD010272308GA SD010272518GA SD010272529GA SD010272531GA SD010272533GA SD010272535GA SD010272536GA SD010272537GA SD010272539GA SD010272541GA SD010272542GA SD010272544GA SD010272545GA SD010272546GA SD010272547GA SD010292708GA SD010292709GA SD010292711GA SD010292836GA SD010292904GA SD010292966GA SD010292968GA SD010292969GA SD010292977GA SD010292978GA SD010292980GA SD010292982GA SD010292984GA SD010292985GA SD010292986GA SD010292987GA SD010292988GA SD010292989GA SD010292990GA SD010292991GA SD010292992GA SD010292993GA SD010292994GA SD010292995GA SD010292996GA SD010292997GA SD010292999GA SD010293000GA SD010293106GA SD010293107GA SD010293108GA SD010293109GA SD010293110GA SD010293113GA SD010293114GA SD010293115GA SD010293116GA SD010293118GA SD010293119GA SD010293120GA SD010293121GA SD010293122GA SD010293123GA SD010293124GA SD010293125GA SD010293126GA SD010293127GA SD010293128GA SD010293129GA SD010293131GA SD010293132GA SD010293133GA SD010293134GA SD010293135GA SD010293136GA SD010293139GA SD010293141GA SD010293142GA SD010293143GA SD010293144GA SD010293145GA SD010293146GA SD010293147GA SD010293148GA SD010303149GA SD010303150GA SD010303152GA SD010303153GA SD010303155GA SD010303156GA SD010303157GA SD010303158GA SD010303159GA SD010303160GA SD010303161GA SD010303162GA SD010303163GA SD010303164GA SD010303165GA SD010303167GA SD010303168GA SD010303169GA SD010303170GA SD010303171GA SD010303172GA SD010303173GA SD010303174GA SD010303175GA SD010303176GA SD010303177GA SD010303178GA SD010303179GA SD010303180GA SD010303181GA SD010303182GA SD010303183GA SD010303184GA SD010303185GA SD010303186GA SD010303188GA SD010303189GA SD010303190GA SD010303191GA SD010303192GA SD010303193GA SD010303194GA SD010303195GA SD010303196GA SD010303290GA SD010303291GA SD010303292GA SD010303293GA SD010303294GA SD010303295GA SD010303296GA SD010303298GA SD010303299GA SD010303300GA SD010303301GA SD010303302GA SD010303303GA SD010303304GA SD010303305GA SD010303306GA SD010303307GA SD010303308GA SD010303309GA SD010303310GA SD010303311GA SD010303312GA SD010303314GA SD010303315GA SD010303316GA SD010303319GA SD010303452GA SD010303454GA SD010303455GA SD010303456GA SD010303457GA SD010303458GA SD010303459GA SD010303460GA SD010303461GA SD010303463GA SD010303464GA SD010303465GA SD010303466GA SD008199261GA SD008231698GA SD008242284GA SD008242289GA SD008242383GA SD008242384GA SD008242385GA SD008242389GA SD008242390GA SD008242395GA SD008242397GA SD008242398GA SD008242399GA SD010460117GA SD010460132GA SD010470347GA SD010502160GA AAB04387686GA DSH05328218GA DSH05328297GA DSH05328299GA DSH05328300GA DSH05338321GA DSH05338324GA DSH05338326GA DSH05338335GA DSH05338338GA DSH05338341GA DSH05338344GA DSH05338345GA DSH05338346GA DSH05338347GA DSH05338351GA DSH05338356GA SBG05452917GA SBG05452971GA SBG05494164GA SBG05525694GA SBG05525745GA SBG06171935GA SBG06483299GA SBG06483306GA SBG07026998GA SBG07152658GA SD007293735GA SD007482771GA SD007482783GA SD007483036GA SD007483038GA SD007493451GA SD007493454GA SD007493456GA SD007493457GA SD008097656GA SD008294161GA SD008325482GA SD008388315GA SD008388319GA SD008409301GA SD008494860GA SD008494862GA SD008494865GA SD008494866GA SD008494867GA SD008494868GA SD008505182GA SD008505183GA SD008505185GA SD008505187GA SD008505188GA SD008505189GA SD008505190GA SD008505191GA SD008505413GA SD008505414GA SD008505416GA SD009255020GA SD009255279GA SD009255281GA SD009255282GA SD009255286GA SD009255308GA SD009255309GA SD010084999GA SD010095254GA SD010105942GA SD010158856GA SD010158859GA SD010158861
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.