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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 Initiated by Firm June 13, 2012
Date Posted February 13, 2013
Recall Status1 Open3, Classified
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, SD009461927GA, SD009461930GA, SD009461936GA, SD009461941GA, SD009461942GA, SD009461943GA, SD009461964GA, SD009461982GA, SD009461983GA, SD009461984GA, SD009461985GA, SD009461986GA, SD009461987GA, SD009461988GA, SD009461989GA, SD009461990GA, SD009461991GA, SD009461992GA, SD009461993GA, SD009461994GA, 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, SD009472274GA, SD009472276GA, SD009472281GA, SD009472283GA, SD009472287GA, SD009472310GA, SD009472311GA, SD009472313GA, SD009472314GA, SD009472316GA, SD009472317GA, SD009472318GA, SD009472319GA, SD009472321GA, SD009472324GA, SD009472326GA, SD009472327GA, SD009472349GA, SD009472350GA, SD009472351GA, SD009472353GA, SD009472355GA, SD009472356GA, SD009472357GA, SD009472358GA, SD009472359GA, SD009472360GA, SD009472361GA, SD009472362GA, SD009472363GA, SD009472364GA, SD009472365GA, SD009472366GA, SD009472367GA, SD009472368GA, SD009472369GA, SD009472371GA, SD009472372GA, SD009472373GA, SD009472374GA, SD009472375GA, SD009472376GA, SD009472377GA, SD009472378GA, SD009472379GA, SD009472380GA, SD009472381GA, SD009472382GA, SD009472383GA, SD009472384GA, SD009472385GA, SD009472386GA, SD009472387GA, SD009472388GA, SD009472389GA, SD009472390GA, SD009472391GA, SD009472392GA, SD009472393GA, SD009472394GA, SD009472395GA, 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
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