• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Dash 3000, Dash 4000 and Dash 5000 Monitor and accessories. see related information
Date Posted February 13, 2013
Recall Status1 Open
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 1878GA
SHQ11491879GA
SHQ11491880GA
SHQ11491881GA
SHQ11491882GA
SHQ11491883GA
SHQ11491884GA
SHQ11491885GA
SHQ11491886GA
SHQ11491887GA
SHQ11491888GA
SHQ11491889GA
SHQ11491890GA
SHQ11491891GA
SHQ11491892GA
SHQ11491893GA
SHQ11491894GA
SHQ11491895GA
SHQ11491896GA
SHQ11491897GA
SHQ11491898GA
SHQ11491899GA
SHQ11491900GA
SHQ11491901GA
SHQ11491902GA
SHQ11491904GA
SHQ11491905GA
SHQ11491906GA
SHQ11491907GA
SHQ11491908GA
SHQ11491909GA
SHQ11491910GA
SHQ11491911GA
SHQ11491912GA
SHQ11491913GA
SHQ11491914GA
SHQ11491915GA
SHQ11491916GA
SHQ11491917GA
SHQ11491933GA
SHQ11491939GA
SHQ11491940GA
SHQ11491941GA
SHQ11491942GA
SHQ11491943GA
SHQ11491944GA
SHQ11491945GA
SHQ11491946GA
SHQ11491947GA
SHQ11491948GA
SHQ11491949GA
SHQ11491950GA
SHQ11491951GA
SHQ11491952GA
SHQ11491953GA
SHQ11491954GA
SHQ11491956GA
SHQ11491957GA
SHQ11491959GA
SHQ11491960GA
SHQ11491961GA
SHQ11491962GA
SHQ11491965GA
SHQ11491966GA
SHQ11491973GA
SHQ11491974GA
SHQ11491976GA
SHQ11491977GA
SHQ11491979GA
SHQ11491980GA
SHQ11491982GA
SHQ11491983GA
SHQ11491986GA
SHQ11491987GA
SHQ11491988GA
SHQ11491989GA
SHQ11491990GA
SHQ11491991GA
SHQ11491992GA
SHQ11491993GA
SHQ11491994GA
SHQ11491997GA
SHQ11491998GA
SHQ11491999GA
SHQ11492000GA
SHQ11492001GA
SHQ11492002GA
SHQ11492003GA
SHQ11492004GA
SHQ11492005GA
SHQ11492006GA
SHQ11492007GA
SHQ11492008GA
SHQ11492009GA
SHQ11502010GA
SHQ11502012GA
SHQ11502013GA
SHQ11502016GA
SHQ11502018GA
SHQ11502019GA
SHQ11502021GA
SHQ11502025GA
SHQ11502026GA
SHQ11502027GA
SHQ11502029GA
SHQ11502166GA
SHQ11512256GA
SHQ11512257GA
SHQ11512258GA
SHQ11512259GA
SHQ11512260GA
SHQ11512261GA
SHQ11512263GA
SHQ11512264GA
SHQ11512265GA
SHQ11512266GA
SHQ11512267GA
SHQ11512268GA
SHQ11512269GA
SHQ11512271GA
SHQ11512272GA
SHQ11512274GA
SHQ11512275GA
SHQ11512276GA
SHQ11512277GA
SHQ11512278GA
SHQ11512279GA
SHQ11512280GA
SHQ11512281GA
SHQ11512282GA
SHQ11512283GA
SHQ11512284GA
SHQ11512285GA
SHQ11512286GA
SHQ11512287GA
SHQ11512288GA
SHQ11512289GA
SHQ11512291GA
SHQ11512293GA
SHQ11512297GA
SHQ11512299GA
SHQ11512300GA
SHQ11512301GA
SHQ11512302GA
SHQ11512309GA
SHQ11512310GA
SHQ11512311GA
SHQ11512312GA
SHQ11512313GA
SHQ11512314GA
SHQ11512315GA
SHQ11512316GA
SHQ12012353GA
SHQ12012376GA
SHQ12012377GA
SHQ12012379GA
SHQ12012380GA
SHQ12012381GA
SHQ12022403GA
SHQ12022404GA
SHQ12022405GA
SHQ12022407GA
SHQ12022408GA
SHQ12022413GA
SHQ12022414GA
SHQ12022422GA
SHQ12022423GA
SHQ12022424GA
SHQ12022428GA
SHQ12022429GA
SHQ12022430GA
SHQ12022431GA
SHQ12022432GA
SHQ12022433GA
SHQ12022434GA
SHQ12022435GA
SHQ12022436GA
SHQ12022437GA
SHQ12022438GA
SHQ12032499GA
SHQ12032500GA
SHQ12032501GAMKE
SHQ12032504GA
SHQ12032505GA
SHQ12032506GA
SHQ12032507GA
SHQ12042509GA
SHQ12042511GA
SHQ12042512GA
SHQ12042515GA
SHQ12042516GA
SHQ12042517GA
SHQ12042534GA
SHQ12042535GA
SHQ12042536GA
SHQ12042537GA
SHQ12042538GA
SHQ12042539GA
SHQ12042540GA
SHQ12042541GA
SHQ12042542GA
SHQ12042543GA
SHQ12042544GA
SHQ12042545GA
SHQ12042546GA
SHQ12042547GA
SHQ12042548GA
SHQ12042549GA
SHQ12042550GA
SHQ12042551GA
SHQ12042552GA
SHQ12042553GA
SHQ12042554GA
SHQ12042555GA
SHQ12042556GA
SHQ12042558GA
SHQ12042559GA
SHQ12042561GA
SHQ12052573GA
SHQ12052574GA
SHQ12052575GA
SHQ12052576GA
SHQ12052578GA
SHQ12052579GA
SHQ12052584GA
SHQ12052591GA
SHQ12052593GA
SHQ12052597GA
SHQ12062617GA
SHQ12062620GA
SHQ12062631GA
SHQ12062633GA
SHQ12072703GA
SHQ12082734GA
SHQ12082758GA
SHQ12082767GA
SHQ12082768GA
SHQ12082769GA
SHQ12082771GA
SHQ12082774GA
SHQ12082775GA
SHQ12082778GA
SHQ12092780GA
SHQ12092782GA
SHQ12092785GA
SHQ12092791GA
SHQ12092793GA
SHQ12092794GA
SHQ12092795GA
SHQ12092796GA
SHQ12092797GA
SHQ12092798GA
SHQ12092799GA
SHQ12092800GA
SHQ12092802GA
SHQ12092803GA
SHQ12092804GA
SHQ12092805GA
SHQ12092807GA
SHQ12092809GA
SHQ12092813GA
SHQ12092814GA
SHQ12092816GA
SHQ12092817GA
SHQ12092818GA
SHQ12092836GA
SHQ12092837GA
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
262-513-4122
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
-
-