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U.S. Department of Health and Human Services

Class 2 Device Recall Dash 3000, Dash 4000 and Dash 5000 Monitor and accessories.

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 Class 2 Device Recall Dash 3000, Dash 4000 and Dash 5000 Monitor and accessories. see related information
Date Posted February 13, 2013
Recall Status1 Terminated
Recall Number Z-0813-2013
Recall Event ID 63654
510(K)Number K073462 
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories.
Code Information 451523GA
SD009451553GA
SD009451562GA
SD009451609GA
SD009451615GA
SD009451664GA
SD009451665GA
SD009451666GA
SD009451667GA
SD009451670GA
SD009451671GA
SD009451672GA
SD009451673GA
SD009451674GA
SD009451675GA
SD009451676GA
SD009451678GA
SD009451681GA
SD009451685GA
SD009451687GA
SD009461752GA
SD009461754GA
SD009461755GA
SD009461757GA
SD009461761GA
SD009461762GA
SD009461763GA
SD009461764GA
SD009461765GA
SD009461766GA
SD009461767GA
SD009461768GA
SD009461769GA
SD009461770GA
SD009461772GA
SD009461773GA
SD009461774GA
SD009461775GA
SD009461776GA
SD009461778GA
SD009461783GA
SD009461846GA
SD009461847GA
SD009461852GA
SD009461858GA
SD009461859GA
SD009461862GA
SD009461866GA
SD009461867GA
SD009461869GA
SD009461871GA
SD009461894GA
SD009461898GA
SD009461906GA
SD009461909GA
SD009461910GA
SD009461911GA
SD009461912GA
SD009461913GA
SD009461924GA
SD009461926GA
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SD009461930GA
SD009461936GA
SD009461941GA
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SD009461964GA
SD009461982GA
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SD009461985GA
SD009461986GA
SD009461987GA
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SD009461989GA
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SD009461993GA
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SD009461995GA
SD009461996GA
SD009461997GA
SD009461998GA
SD009461999GA
SD009462000GA
SD009462001GA
SD009462002GA
SD009472123GA
SD009472124GA
SD009472125GA
SD009472126GA
SD009472128GA
SD009472129GA
SD009472130GA
SD009472131GA
SD009472132GA
SD009472133GA
SD009472134GA
SD009472174GA
SD009472177GA
SD009472180GA
SD009472181GA
SD009472269GA
SD009472270GA
SD009472271GA
SD009472272GA
SD009472273GA
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SD009472276GA
SD009472281GA
SD009472283GA
SD009472287GA
SD009472310GA
SD009472311GA
SD009472313GA
SD009472314GA
SD009472316GA
SD009472317GA
SD009472318GA
SD009472319GA
SD009472321GA
SD009472324GA
SD009472326GA
SD009472327GA
SD009472349GA
SD009472350GA
SD009472351GA
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SD009472355GA
SD009472356GA
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SD009472378GA
SD009472379GA
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SD009472381GA
SD009472382GA
SD009472383GA
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SD009472385GA
SD009472386GA
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SD009472389GA
SD009472390GA
SD009472391GA
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SD009472393GA
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SD009472397GA
SD009472398GA
SD009472400GA
SD009472401GA
SD009472403GA
SD009472404GA
SD009472407GA
SD009472410GA
SD009472411GA
SD009472412GA
SD009472414GA
SD009472415GA
SD009472417GA
SD009472418GA
SD009472421GA
SD009472428GA
SD009472429GA
SD009472434GA
SD009472435GA
SD009472436GA
SD009472442GA
SD009482463GA
SD009482464GA
SD009482465GA
SD009482466GA
SD009482468GA
SD009482519GA
SD009482520GA
SD009482524GA
SD009482526GA
SD009492597GA
SD009492620GA
SD009492622GA
SD009492623GA
SD009492624GA
SD009492626GA
SD009492627GA
SD009492634GA
SD009492651GA
SD009492652GA
SD009492653GA
SD009492654GA
SD009492657GA
SD009492698GA
SD009492699GA
SD009492700GA
SD009492701GA
SD009492729GA
SD009492730GA
SD009492731GA
SD009492732GA
SD009492733GA
SD009492734GA
SD009492735GA
SD009492736GA
SD009492737GA
SD009492738GA
SD009492758GA
SD009502828GA
SD009502829GA
SD009502830GA
SD009502832GA
SD009502833GA
SD009502834GA
SD009502835GA
SD009502836GA
SD009502837GA
SD009502838GA
SD009502839GA
SD009502942GA
SD009502943GA
SD009502944GA
SD009502946GA
SD009502948GA
SD009502949GA
SD009502951GA
SD009502952GA
SD009502954GA
SD009502957GA
SD009502959GA
SD009502961GA
SD009502963GA
SD009502967GA
SD009502968GA
SD009502990GA
SD009502993GA
SD009502994GA
SD009502995GA
SD009502996GA
SD009502997GA
SD009502998GA
SD009503000GA
SD009503001GA
SD009503002GA
SD009503003GA
SD009503004GA
SD009503005GA
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
Nonconforming Material/Component
Action 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.
Quantity in Commerce 119,262
Distribution 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
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
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