GE Healthcare…

Date

Feb. 20, 2013

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

GE Healthcare, LLC

Product

GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories.

Reason

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

Distribution pattern

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

Quantity

119,262

Codes and lots

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 SD010158861GA SD010159035GA SD010355712GA SD010355716GA SD010355721GA SD010355723GA SD010366099GA SD010366226GA SD010366256GA SD010366342GA SD010366354GA SD010366359GA SD011093737GA SD011093738GA SD011093740GA SD011093749GA SD011144492GA SD011144495GA SD011144496GA SD011144509GA SD011154612GA SD011154613GA SD011154614GA SD011154615GA SD011154616GA SD011154618GA SD011154619GA SD011154620GA SD011154622GA SD011154625GA SD011154626GA SD011154627GA SD011154630GA SD011164690GA SD011164696GA SD011164697GA SD011164701GA SD011164702GA SD011164704GA SD011164705GA SD011164706GA SD011164708GA SD011164710GA SD011215071GA SHQ11421356GA SHQ11441370GA SHQ11441374GA SHQ12217862SA AAB04160083GA AAB04180134GA AAB04180158GA AAB04180172GA AAB04180173GA AAB04180229GA AAB04180230GA AAB04180231GA AAB04180232GA AAB04180234GA AAB04190382GA AAB04190386GA AAB04210695GA AAB04220861GA AAB04220865GA AAB04220869GA AAB04221020GA AAB04233721GA AAB04233737GA AAB04233738GA AAB04233845GA AAB04244072GA AAB04244173GA AAB04244175GA AAB04244176GA AAB04244177GA AAB04244178GA AAB04244179GA AAB04244180GA AAB04244186GA AAB04244188GA AAB04254227GA AAB04254385GA AAB04254386GA AAB04254387GA AAB04295276GA AAB04302530GA AAB04305694GA AAB04305742GA AAB04305749GA AAB04315901GA AAB04346659GA AAB04356788GA AAB04356889GA AAB04356946GA AAB04356947GA AAB04356985GA AAB04397899GA AAB04397997GA AAB04408266GA AAB04408268GA AAB04408269GA AAB04408270GA AAB04408271GA AAB04408277GA AAB04408348GA AAB04408380GA AAB04408421GA AAB04418607GA AAB04418637GA AAB04418649GA AAB04418722GA AAB04418750GA AAB04428949GA AAB04428952GA AAB04429076GA AAB04429077GA AAB04469813GA DSH04440040GA DSH04480669GA DSH04480670GA DSH04480717GA DSH04511487GA DSH04511650GA DSH04521855GA DSH04521856GA DSH04521867GA DSH04521888GA DSH05012126GA DSH05012231GA DSH05012232GA DSH05012234GA DSH05012235GA DSH05022297GA DSH05022298GA DSH05022299GA DSH05022469GA DSH05022558GA DSH05032733GA DSH05032753GA DSH05032818GA DSH05032853GA DSH05032859GA DSH05032860GA DSH05053317GA DSH05063515GA DSH05083889GA DSH05083987GA DSH05094077GA DSH05155330GA DSH05155388GA DSH05165453GA DSH05193054GA DSH05193056GA DSH05199957GA DSH05211327GA DSH05211423GA DSH05211473GA DSH05242162GA DSH05242174GA DSH05242186GA DSH05252328GA DSH05252336GA DSH05252340GA DSH05252399GA DSH05252441GA DSH05252442GA DSH05252444GA DSH05252458GA DSH05252461GA DSH05252463GA DSH05252464GA DSH05252466GA DSH05252492GA DSH05252496GA DSH05252503GA DSH05252531GA DSH05282612GA DSH05282625GA DSH05282782GA DSH05282788GA DSH05282790GA DSH05282841GA DSH05292883GA DSH05292891GA DSH05292921GA DSH05292922GA DSH05292924GA DSH05292925GA DSH05318033GA DSH05318051GA DSH05318079GA DSH05318081GA DSH05318107GA DSH05328254GA DSH05328303GA DSH05348726GA DSH05358897GA DSH05369023GA DSH05369028GA DSH05369068GA DSH05369070GA SBG05260072GA SBG05391166GA SBG05401400GA SBG05401407GA SBG05411589GA SBG05421878GA SBG05421942GA SBG05421981GA SBG05421985GA SBG05422013GA SBG05422026GA SBG05432201GA SBG05432222GA SBG05432225GA SBG05432228GA SBG05432229GA SBG05452949GA SBG05452953GA SBG05463246GA SBG05463263GA SBG05473577GA SBG05483704GA SBG05483717GA SBG05483720GA SBG05483730GA SBG05483732GA SBG05483733GA SBG05483734GA SBG05483740GA SBG05483748GA SBG05483751GA SBG05483755GA SBG05483804GA SBG05483935GA SBG05483944GA SBG05483966GA SBG05483972GA SBG05494136GA SBG05494137GA SBG05494138GA SBG05494139GA SBG05494144GA SBG05494195GA SBG05504740GA SBG05504742GA SBG05504744GA SBG05504751GA SBG05515010GA SBG05515012GA SBG05515147GA SBG05515151GA SBG05525588GA SBG06036271GA SBG06036278GA SBG06036279GA SBG06046661GA SBG06056771GA SBG06056802GA SBG06067192GA SBG06077338GA SBG06077340GA SBG06077661GA SBG06077663GA SBG06077669GA SBG06087865GA SBG06087970GA SBG06088057GA SBG06098287GA SBG06098451GA SBG06108916GA SBG06108992GA SBG06119174GA SBG06119231GA SBG06119274GA SBG06139807GA SBG06139809GA SBG06139810GA SBG06141005GA SBG06141007GA SBG06141009GA SBG06141010GA SBG06141016GA SBG06141022GA SBG06141023GA SBG06141026GA SBG06141027GA SBG06141049GA SBG06141051GA SBG06141057GA SBG06151202GA SBG06151209GA SBG06151213GA SBG06151487GA SBG06151493GA SBG06151494GA SBG06151496GA SBG06151500GA SBG06151501GA SBG06151502GA SBG06151548GA SBG06151552GA SBG06151561GA SBG06161707GA SBG06161815GA SBG06161816GA SBG06161818GA SBG06161865GA SBG06161866GA SBG06161868GA SBG06171955GA SBG06171968GA SBG06171998GA SBG06172091GA SBG06172146GA SBG06172147GA SBG06172176GA SBG06172181GA SBG06182246GA SBG06182296GA SBG06182426GA SBG06182430GA SBG06192513GA SBG06192515GA SBG06192586GA SBG06192651GA SBG06192745GA SBG06192750GA SBG06202845GA SBG06202847GA SBG06202848GA SBG06202853GA SBG06202856GA SBG06202859GA SBG06202947GA SBG06202953GA SBG06202983GA SBG06202998GA SBG06202999GA SBG06203000GA SBG06203001GA SBG06203051GA SBG06233647GA SBG06243837GA SBG06243918GA SBG06244106GA SBG06244107GA SBG06244110GA SBG06244112GA SBG06244116GA SBG06254447GA SBG06264679GA SBG06284971GA SBG06284975GA SBG06284982GA SBG06284983GA SBG06295562GA SBG06305669GA SBG06315970GA SBG06316136GA SBG06326372GA SBG06336504GA SBG06336506GA SBG06336507GA SBG06336509GA SBG06336510GA SBG06336512GA SBG06336552GA SBG06336559GA SBG06336656GA SBG06336659GA SBG06346739GA SBG06357180GA SBG06387979GA SBG06398418GA SBG06398479GA SBG06409102GA SBG06419407GA SBG06429485GA SBG06429489GA SBG06429493GA SBG06429501GA SBG06429506GA SBG06429574GA SBG06429608GA SBG06439671GA SBG06439836GA SBG06441010GA SBG06441016GA SBG06441064GA SBG06441110GA SBG06441140GA SBG06441150GA SBG06441156GA SBG06441158GA SBG06441159GA SBG06441167GA SBG06441168GA SBG06441170GA SBG06441333GA SBG06449953GA SBG06449954GA SBG06449956GA SBG06449957GA SBG06449958GA SBG06449960GA SBG06449962GA SBG06449963GA SBG06449964GA SBG06449965GA SBG06449966GA SBG06449967GA SBG06449968GA SBG06449969GA SBG06449970GA SBG06451446GA SBG06451494GA SBG06451530GA SBG06451531GA SBG06451536GA SBG06451753GA SBG06451755GA SBG06451758GA SBG06451787GA SBG06451801GA SBG06451802GA SBG06451804GA SBG06451805GA SBG06452074GA SBG06452075GA SBG06452077GA SBG06452093GA SBG06452094GA SBG06452097GA SBG06462236GA SBG06462238GA SBG06462247GA SBG06462574GA SBG06462576GA SBG06462608GA SBG06482970GA SBG06482976GA SBG06482977GA SBG06482980GA SBG06483084GA SBG06483095GA SBG06483163GA SBG06483164GA SBG06483209GA SBG06483211GA SBG06483212GA SBG06483241GA SBG06483244GA SBG06493754GA SBG06493755GA SBG06493756GA SBG06493757GA SBG06493758GA SBG06493915GA SBG06493916GA SBG06493917GA SBG06493918GA SBG06493920GA SBG06493922GA SBG06493923GA SBG06494051GA SBG06494057GA SBG06494080GA SBG06494083GA SBG06494084GA SBG06494191GA SBG06494196GA SBG06504388GA SBG06504391GA SBG06504507GA SBG06504508GA SBG06515229GA SBG06515230GA SBG06515355GA SBG06515377GA SBG06515500GA SBG06515521GA SBG06515522GA SBG06515694GA SBG06525795GA SBG06525952GA SBG06525953GA SBG06526174GA SBG06526232GA SBG06526293GA SBG06526296GA SBG07026780GA SBG07037056GA SBG07037064GA SBG07047282GA SBG07047351GA SBG07057423GA SBG07057432GA SBG07057434GA SBG07057435GA SBG07077613GA SBG07077617GA SBG07077619GA SBG07077621GA SBG07077623GA SBG07077624GA SBG07077625GA SBG07077626GA SBG07077639GA SBG07077761GA SBG07087936GA SBG07098322GA SBG07098351GA SBG07098358GA SBG07098359GA SBG07098375GA SBG07098377GA SBG07098379GA SBG07098477GA SBG07098478GA SBG07098479GA SBG07098556GA SBG07098560GA SBG07108929GA SBG07108932GA SBG07108933GA SBG07109137GA SBG07109138GA SBG07109185GA SBG07109198GA SBG07109200GA SBG07109202GA SBG07109205GA SBG07109257GA SBG07111099GA SBG07119904GA SBG07121644GA SBG07121721GA SBG07132083GA SBG07132088GA SBG07132089GA SBG07142132GA SBG07142133GA SBG07142135GA SBG07142139GA SBG07142150GA SBG07142161GA SBG07142164GA SBG07142205GA SBG07142258GA SBG07142267GA SBG07142268GA SBG07142272GA SBG07142276GA SBG07142371GA SBG07142378GA SBG07142380GA SBG07142381GA SBG07152487GA SBG07152490GA SBG07152491GA SBG07152494GA SBG07152497GA SBG07152505GA SBG07152523GA SBG07162861GA SBG07173118GA SBG07183541GA SBG07183571GA SBG07183577GA SBG07183622GA SBG07183629GA SBG07183633GA SBG07183690GA SBG07183771GA SD007210473GA SD007220798GA SD007220799GA SD007220800GA SD007220801GA SD007220802GA SD007220803GA SD007220804GA SD007220805GA SD007220806GA SD007220807GA SD007220810GA SD007220811GA SD007220812GA SD007220813GA SD007220815GA SD007220816GA…

Recall started

June 13, 2012

Device type

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Root cause (FDA)

Nonconforming Material/Component

What the company told customers

GE Healthcare sent an Important Product Information letter dated June 13, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were told the otherboard would be replaced, on request, should the customer continue to expeience the issue with the affected product. A second letter dated August 30, 2012, was sent on September 5, 2012, informing consignees that the motherboard replacement did not fully correct the issues. Therefore, the motherboard replacement field action had been suspended. It further explained that the correction will be provided when it is available. Customers with questions were instructed to call 1-800-558-7044. For questions regarding this recall call 262-513-4122.

Recall number

Z-0813-2013

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0813-2013. The agency record governs; check it and the company before acting.