FDAFDA · Food and drugs·Recall number Z-2115-2013
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Published September 4, 2013 · Recall initiated: April 3, 2013
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 Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH, PDM, and/or Tram Module. ECG and Respiration signal noise caused by DASH, PDM, and/or Tram ECG cable connector movement may result in reduced ECG, Respiration and arrhythmia detection performance.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- Worldwide Distribution - USA Nationwide including DC and PR except ND and the countries of: ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOSNIA-HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, CHANA, GREECE, HONDURAS, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, MALAYSIA, MEXICO, MOROCCO, NEPAL, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, PANAMA, PARAGUAY, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAK IA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNSIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, BOLIVIA, HONG KONG, JAMAICA, PHILIPPINES, SOUTH KOREA, TRINIDAD TOBAGO, URUGUAY, VENEZUELA.
- Lot
- Mfg Lot or Serial # AAB04397901GR SD007210479GR SD007231230GR SD007241751GR SD007366729GR SD007387285GR SD007387288GR SD007387291GR SD007387292GR SD007387294GR SD007439614GR SD008056174GR SD008076950GR SD008087478GR SD008138396GR SD008168769GR SD008219818GR SD008219821GR SD008356627GR SD008388272GR SD008388551GR SD008419461GR SD008419463GR SD008419495GR SD008421124GR SD008429787GR SD008429950GR SD008452355GR SD008452399GR SD008463177GR SD008516155GR SD008516281GR SD009037533GR SD009047690GR SD009088931GR SD009088944GR SD009099025GR SD009119669GR SD009121032GR SD009121171GR SD009129978GR SD009141371GA SD009141699GR SD009151940GA SD009182687GR SD009182701GR SD009182715GR SD009193075GR SD009193076GR SD009193084GR SD009193086GR SD009223767GR SD009223886GR SD009234001GR SD009234021GR SD009244557GR SD009244558GR SD009244559GR SD009244560GR SD009244564GR SD009244732GR SD009244820GR SD009255010GR SD009316784GR SD009316799GR SD009316886GR SD009316887GR SD009316899GR SD009316900GR SD009316901GR SD009316906GR SD009316909GR SD009316914GR SD009316918GR SD009316928GR SD009316933GR SD009317060GR SD009327366GR SD009327369GR SD009327371GR SD009327375GR SD009327376GR SD009358078GR SD009358079GR SD009368552GR SD009368640GR SD009400079GR SD009400082GR SD009400090GR SD009400096GR SD009400105GR SD009400109GR SD009409707GR SD009409720GR SD009409722GR SD009409748GR SD009409757GR SD009409767GR SD009409773GR SD009420737GR SD009472159GR SD009472167GR SD009513762GA SD010054455GR SD010074910GA SD010085194GR SD010095383GR SD010105782GR SD010116508GR SD010127167GR SD010127275GR SD010127663GR SD010127727GR SD010127744GA SD010127745GR SD010127802GR SD010127803GR SD010127804GR SD010127808GR SD010127809GR SD010127814GR SD010127815GR SD010138406GA SD010138409GA SD010138435GR SD010138442GA SD010138469GR SD010138494GR SD010148544GA SD010148546GA SD010148550GA SD010148560GR SD010148561GR SD010148656GR SD010148660GR SD010148692GR SD010148707GR SD010148711GR SD010148712GA SD010148719GR SD010148722GR SD010158817GR SD010158820GR SD010158981GR SD010159059GR SD010159065GR SD010179591GA SD010189668GR SD010189669GR SD010199870GA SD010199872GA SD010209915GA SD010209920GA SD010209972GA SD010210554GA SD010220665GR SD010220672GR SD010220683GR SD010241191GR SD010241193GR SD010251365GA SD010251520GA SD010261863GA SD010261884GR SD010261920GA SD010262032GR SD010262037GR SD010262052GR SD010262054GR SD010262058GR SD010272265GA SD010272311GA SD010272336GA SD010272351GA SD010272356GA SD010272361GA SD010272362GA SD010272435GA SD010272523GA SD010292604GA SD010292606GA SD010292653GA SD010292710GA SD010292766GA SD010292798GA SD010292838GA SD010292847GR SD010292927GA SD010292934GA SD010292976GA SD010293096GA SD010293101GA SD010293105GA SD010293130GA SD010293137GA SD010293140GA SD010303154GA SD010303318GA SD010303373GA SD010303415GA SD010303438GA SD010303453GA SD010303518GA SD010303527GA SD010303547GA SD010303620GA SD010313737GA SD010313739GA SD010313744GA SD010313748GA SD010313750GA SD010313752GA SD010313757GA SD010313758GA SD010313767GA SD010313768GA SD010313781GA SD010313794GA SD010313796GA SD010313798GA SD010313826GA SD010313828GA SD010313844GA SD010313845GA SD010313852GA SD010313854GA SD010313856GA SD010313863GA SD010313867GA SD010313875GA SD010313878GA SD010313886GA SD010313920GA SD010313948GA SD010313953GA SD010313992GA SD010313997GA SD010314032GA SD010314112GA SD010314117GA SD010314123GA SD010314149GA SD010314150GA SD010314159GA SD010314161GA SD010314168GA SD010314172GA SD010314256GA SD010314259GA SD010314262GA SD010314293GA SD010314305GA SD010314357GA SD010314359GA SD010314360GA SD010314361GA SD010314362GA SD010314364GA SD010314367GA SD010314369GA SD010314401 SD010314407GA SD010314418GA SD010314419GA SD010314421GA SD0103
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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