FDA · Medical device recall

GE Healthcare… and 2 more products

Sept. 4, 2013 Class II

Date: Sept. 4, 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
Reason: 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.
Distribution pattern: 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.

3 products in this recall

GE Healthcare…

Product: 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.
Quantity: 28,120 *14,709 US & 13,411 OUS)
Codes and lots: 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 SD010314423GA SD010314426GA SD010314427GA SD010314428GA SD010324430GA SD010324433GA SD010324434GA SD010324435GA SD010324476GA SD010324484GA SD010324485GA SD010324495GA SD010324497GA SD010324515GA SD010324527GA SD010324561GA 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SD010335176GA SD010335177GA SD010335178GA SD010335179GA SD010335182GA SD010335183GA SD010335185GA SD010335188GA SD010335194GA SD010345212GA SD010345213GA SD010345215GA SD010345217GA SD010345219GA SD010345220GA SD010345235GA SD010345240GA SD010345244GA SD010345246GA SD010345248GA SD010345272GA SD010345278GA SD010345279GA SD010345280GA SD010345281GA SD010345282GA SD010345284GA SD010345285GA SD010345286GA SD010345288GA SD010345290GA SD010345291GA SD010345292GA SD010345295GA SD010345300GA SD010345317GA SD010345318GA SD010345319GA SD010345345GA SD010345351GA SD010345352GA SD010345356GA SD010345358GA SD010345359GA SD010345362GA SD010345378GA SD010345385GA SD010345390GA SD010345391GA SD010345397GA SD010345408GA SD010345413GA SD010345415GA SD010345417GA SD010345418GA SD010345420GA SD010345423GA SD010345433GA SD010345450GA SD010345457GA SD010345459GA SD010345462GA SD010345463GA SD010345464GA SD010345466GA SD010345467GA SD010345468GA SD010345470GA SD010345471GA SD010345484GA SD010345486GA SD010345490GA SD010345494GA SD010345497GAMKE SD010345498GA SD010345499GA SD010345500GA SD010345501GA SD010345505GA SD010345507GA SD010345518GA SD010345526GA SD010345530GA SD010345532GA SD010345536GA SD010345543GA SD010345549GA SD010355564GA SD010355577GA SD010355720GA SD010365928GA SD010365975GA SD010365976GR SD010365981GA SD010366046GA SD010366058GA SD010366059GA SD010366060GR SD010366062GR SD010366064GR SD010366066GA SD010366112GA SD010366135GA SD010366163GA SD010366164GA SD010366183GA SD010366184GA SD010366186GA SD010366187GA SD010366188GA SD010366255GA SD010366289GA SD010366290GA SD010366292GA SD010366294GA SD010366296GA SD010366301GA SD010366318GR SD010366397GA SD010366413GA SD010366421GA SD010366434GA SD010366462GA SD010366464GA SD010366465GA SD010366466GA SD010366467GA SD010366469GA SD010366470GA SD010366471GA SD010366472GA SD010366473GA SD010366508GA SD010366511GA SD010366514GA SD010366522GA SD010366525GA SD010366533GA SD010376553GA SD010376565GA SD010376573GA SD010376588GA SD010376606GA SD010376613GA SD010376617GA SD010376618GA SD010376619GA SD010376620GA SD010376621GA SD010376622GA SD010376631GA SD010376632GA SD010376635GA SD010376636GA SD010376637GA SD010376640GA SD010376647GA SD010376648GA SD010376651GA SD010376669GA SD010376677GA SD010376681GA SD010376709GA SD010376710GA SD010376711GA SD010376715GA SD010376716GA SD010376717GA SD010376718GA SD010376722GA SD010376723GA SD010376726GA SD010376727GA SD010376728GA SD010376729GA SD010376734GA SD010376738GA SD010376787GA SD010376806GA SD010376809GA SD010376814GA SD010376817GA SD010376818GA SD010376819GA SD010376820GA SD010376821GA SD010376824GA SD010376826GA SD010376827GA SD010376951GA SD010376952GA SD010376953GA SD010376955GA SD010376956GA SD010376957GA SD010376960GA SD010376961GA SD010376965GA SD010376966GA SD010376967GA SD010376968GA SD010376969GA SD010376972GA SD010376973GA SD010376974GA SD010376976GA SD010376977GA SD010377021GA SD010377023GA SD010377024GA SD010377025GA SD010377028GA SD010377029GA SD010377031GA SD010377034GA SD010377035GA SD010377038GA SD010377039GA SD010377041GA SD010377044GA SD010377046GA SD010377048GA SD010377049GA SD010377050GA SD010377051GA SD010377052GA SD010377054GA SD010377055GA SD010377056GA SD010377057GA SD010377066GA SD010377072GA SD010377119GA SD010377136GA SD010377137GA SD010377155GA SD010377157GA SD010377158GA SD010377159GA SD010377160GA SD010377161GA SD010377162GA SD010377168GA SD010377169GA SD010377172GA SD010377174GA SD010377176GA SD010377178GA SD010377181GA SD010387182GA SD010387183GA SD010387184GA SD010387185GA SD010387186GA SD010387190GA SD010387191GA SD010387194GA SD010387196GA SD010387199GA SD010387201GA SD010387202GA SD010387203GA SD010387204GA SD010387205GA SD010387211GA SD010387218GA SD010387219GA SD010387220GA SD010387223GA SD010387226GA SD010387229GA SD010387231GA SD010387236GA SD010387237GA SD010387302GA SD010387307GA SD010387308GA SD010387310GA SD010387311GA SD010387314GA SD010387315GA SD010387316GA SD010387322GA SD010387334GA SD010387335GA SD010387336GA SD010387337GA SD010387338GA SD010387339GA SD010387340GA SD010387341GA SD010387342GA SD010387343GA SD010387344GA SD010387345GA SD010387346GA SD010387347GA SD010387349GA SD010387350GA SD010387351GA SD010387352GA SD010387353GA SD010387354GA SD010387355GA SD010387356GA SD010387357GA SD010387359GA SD010387362GA SD010387365GA SD010387366GA SD010387380GA SD010387381GA SD010387383GA SD010387403GA SD010387417GA SD010387418GA SD010387421GA SD010387422GA SD010387428GA SD010387433GA SD010387442GA SD010387443GA SD010387444GA SD010387446GA SD010387447GA SD010387448GA SD010387449GA SD010387450GA SD010387451GA SD010387480GA SD010387493GA SD010387515GA SD010387519GA SD010387525GA SD010387527GA SD010387533GA SD010387541GA SD010387542GA SD010387549GA SD010387552GA SD010387570GA SD010387571GA SD010387572GA SD010387591GA SD010387592GA SD010387595GA SD010387597GA SD010387598GA SD010387599GA SD010387601GA SD010387602GA SD010387603GA SD010387604GA SD010387605GA SD010387607GA 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SD010387785GA SD010387786GA SD010387787GA SD010387816GA SD010387825GA SD010387827GA SD010387830GA SD010387831GA SD010387834GA SD010387841GA SD010387844GA SD010387846GA SD010387847GA SD010387850GA SD010387851GA SD010387856GA SD010397918GA SD010397919GA SD010397920GA SD010397921GA SD010397922GA SD010397923GA SD010397925GA SD010397926GA SD010397927GA SD010397928GA SD010397929GA SD010397930GA SD010397931GA SD010397933GA SD010397934GA SD010397936GA SD010397937GA SD010397939GA SD010397940GA SD010397941GA SD010397942GA SD010397943GA SD010397945GA SD010397946GA SD010397947GA SD010397990GA SD010397996GA SD010397997GA SD010397998GA SD010398001GA SD010398002GA SD010398003GA SD010398006GA SD010398007GA SD010398008GA SD010398009GA SD010398010GA SD010398011GA SD010398012GA SD010398013GA SD010398014GA SD010398015GA SD010398016GA SD010398017GA SD010398018GA SD010398020GA SD010398021GA SD010398025GA SD010398026GA SD010398030GA SD010408033GA SD010408034GA SD010408035GA SD010408036GA SD010408037GA SD010408039GA SD010408040GA SD010408043GA SD010408045GA SD010408046GA SD010408063GA…
Recall started: April 3, 2013
Device type: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Root cause (FDA): Nonconforming Material/Component
What the company told customers: GE Healthcare "Urgent Medical Device Correction" letter dated April 3, 2013 to all affected customers. The letter was addressed to Healthcare Administrator / Risk manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Product, Safety Instructions, Affected Product Details, and Product Correction. For questions contact Technical Support at 1-800-558-7044.
Recall number: Z-2115-2013

SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data…

Product: SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes.
Quantity: 16,462 (8497 US, 7307 OUS, & 658 unlocated)
Codes and lots: Mfg Lot or Serial # SA310290653GA SA310290655GA SA310290657GA SA310290659GA SA310290661GA SA310290748GA SA310290749GA SA310290750GA SA310290754GA SA310290755GA SA310290756GA SA310290757GA SA310290758GA SA310290759GA SA310361647GA SA310361877GA SA310372108GA SA310393017GA SA310393052GA SA310382648GA SA310382626GA SA310382631GA SA310382729GA SA310382761GA SA310393037GA SA310393054GA SA310393071GA SA310393073GA SA310351531GA SA310361792GA SA310361798GA SA310361801GA SA310361803GA SA310361804GA SA310361805GA SA310361807GA SA310361808GA SA310361815GA SA310361820GA SA310361838GA SA310361840GA SA310361841GA SA310393150GA SA310393155GA SA310393162GA SA310393165GA SA310393166GA SA310393167GA SA310393170GA SA310393171GA SA310393173GA SA310393175GA SA310321055GA SA310321062GA SA310361949GA SA310382418GA SA310382450GA SA310382499GA SA310382513GA SA310382608GA SA310382647GA SA310382649GA SA310382663GA SA310393156GA SA310393158GA SA310393164GA SA310393169GA SA310393177GA SA310259944GA SA310331337GA SA310331342GA SA310331343GA SA310331345GA SA310331349GA SA310331351GA SA310341373GA SA310341376GA SA310341387GA SA310341388GA SA310341399GA SA310341400GA SA310341401GA SA310341402GA SA310341403GA SA310341406GA SA310382386GA SA310382391GA SA310382472GA SA310382476GA SA310382477GA SA310382479GA SA310382484GA SA310382494GA SA310382618GA SA310382619GA SA310382634GA SA310382636GA SA310382645GA SA310382378GA SA310382449GA SA310382511GA SA310382606GA SA310382607GA SA310382610GA SA310382612GA SA310382613GA SA310382615GA SA310382616GA SA310382642GA SA310382652GA SA310382656GA SA310382664GA SA310423572GA SA310423573GA SA310290745GA SA310290753GA SA310413471GA SA310413476GA SA310423587GA SA310423607GA SA310413493GA SA310413498GA SA310413500GA SA310413507GA SA310413514GA SA310413524GA SA310413535GA SA310423604GA SA310423606GA SA310423611GA SA310423617GA SA310423619GA SA310423621GA SA310423626GA SA310423640GA SA310423649GA SA310423650GA SA310423730GA SA310423821GA SA310423825GA SA310423836GA SA310423838GA SA310423842GA SA310423864GA SA310423929GA SA310423935GA SA310423943GA SA310423959GA SA310423962GA SA310424000GA SA310424001GA SA310424017GA SA310413491GA SA310413499GA SA310413509GA SA310413511GA SA310413538GA SA310423613GA SA310423614GA SA310423618GA SA310423622GA SA310423628GA SA310423637GA SA310423639GA SA310423663GA SA310423709GA SA310423933GA SA310423937GA SA310423946GA SA310423950GA SA310423953GA SA310423956GA SA310423957GA SA310423960GA SA310423961GA SA310423967GA SA310423971GA SA310424002GA SA310424003GA SA310424004GA SA310424006GA SA310424008GA SA310424025GA SA310424027GAMKE SA310424033GA SA310424034GAMKE SA310424039GA SA310424046GA SA310434199GAMKE SA310434200GA SA310434204GAMKE SA310434205GA SA310434207GAMKE SA310434208GA SA310434210GA SA310434211GAMKE SA310434212GA SA310434213GA SA310434227GAMKE SA310434238GA SA310444247GAMKE SA310444253GAMKE SA310372179GA SA310382540GA SA310382541GA SA310382542GA SA310382544GA SA310382550GA 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SA310454987GA SA310454988GA SA310454994GA SA310455012GA SA310455024GA SA310455025GA…
Recall started: April 3, 2013
Device type: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Root cause (FDA): Nonconforming Material/Component
What the company told customers: GE Healthcare "Urgent Medical Device Correction" letter dated April 3, 2013 to all affected customers. The letter was addressed to Healthcare Administrator / Risk manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Product, Safety Instructions, Affected Product Details, and Product Correction. For questions contact Technical Support at 1-800-558-7044.
Recall number: Z-2116-2013

GE Healthcare…

Product: GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another.
Quantity: 4807 (2167 US, 2207 OUS, & 434 unknown.
Codes and lots: Mfg Lot or Serial # RT412081449GA RT412081483GA RT412091489GA RT412091490GA RT412091492GA RT412091510GA RT412091511GA RT412091517GA RT412091522GA SBB12281535GA RT412101534GA SBB12281525GA SBB12281528GA SBB12281561GA SBB12301640GA SBB12361656GA SBB12361658GA SBB12361659GA SBB12361660GA SBB12361661GA SBB12361662GA SBB12361663GA SBB12301635GA RT411220584GA RT412081484GA RT412091488GA RT412091501GA RT412101576GA RT412101599GA RT412101601GA RT412101604GA RT412101605GA RT412101606GA RT412101609GA RT412101611GA RT412101621GA RT412101624GA RT412101626GA RT412101628GA RT412101629GA RT412101632GA RT412101646GA RT412101655GA RT412101657GA RT412101661GA RT412101662GA RT412101663GA RTW11346657GA RTW11346667GA RTW11366669GA RTW11366672GA RTW11366673GA RTW11366674GA RTW11366691GA RTW11366695GA RTW11366697GA RTW11366700GA RTW11366701GA RTW11366702GA RTW11366704GA RTW11366712GA RTW11366715GAMKE RTW11366721GA RTW11366722GA RTW11366724GA RTW11366725GA RTW11366726GA RTW11366731GA RTW11366736GA RTW11366737GA RTW11366738GA RTW11366739GA RTW11366742GA RTW11366747GA RTW11366748GA RTW11366751GA RTW11366752GA SBB12281564GA SBB12281575GA SBB12301617GA SBB12301618GA SBB12301620GA SBB12301626GA SBB12301627GA SBB12301628GA SBB12301630GA SBB12301631GA SBB12131373GA SBB12301629GA SBB12281536GA SBB12281539GA SBB12281542GA SBB12281549GA SBB12281563GA SBB12301623GA SBB12301624GA SBB12301632GA SBB12301633GA SBB12301634GA SBB12301636GA SBB12301637GA SBB12301638GA SBB12301639GA SBB12301641GA SBB12301642GA SBB12301643GA SBB12301644GA SBB12301645GA SBB12301646GA RT412081429GA RT412081448GA RT412091507GA RT412101533GA RT412101536GA RTW11366717GA RTW11366732GA RTW11376817GA RTW11376819GA RTW11376821GA SBB12281533GA SBB12281537GA SBB12281538GA SBB12281540GA SBB12281545GA SBB12281548GA SBB12281551GA SBB12281552GA SBB12281553GA SBB12281554GA SBB12281556GA SBB12281557GA SBB12281558GA SBB12281562GA SBB12281565GA SBB12281566GA SBB12281574GA SBB12281576GA SBB12301621GA SBB12301622GA SBB12301625GA RTW11366716GA SBB12281547GA SBB12281559GA SBB12281531GA RT412101598GA SBB12261509GA SBB12281546GA RT412101597GA RT412101600GA RT412101603GA RT412101615GA RT412101633GA RT412101637GA SBB12281526GA SBB12281529GA RTW11366684GA RTW11366687GA RTW11366688GA RTW11366694GA RTW11366696GA RTW11366720GA SBB12281522GA SBB12281523GA SBB12281527GA SBB12281532GA RT412101660GA SBB12261508GA SBB12261510GA SBB12261511GA SBB12261512GA SBB12261514GA RT412081435GA RT412091498GA RT412091512GA RT412091515GA RT412101563GA RT412101588GA RT412101590GA RTW11245985GA SBB12111305GA SBB12121312GA SBB12121318GA SBB12121322GA SBB12131356GA SBB12131365GA SBB12131379GA SBB12131386GA SBB12131396GA SBB12131398GA RTW11316250GA RTW11316392GA RTW11346656GA RTW11366685GA RTW11366692GA SBB12131402GA SBB12131408GA SBB12131393GA SBB12131391GA SBB12131409GA RTW11346632GA RTW11346640GA RTW11346642GA RTW11366777GA RTW11376799GA SBB12131392GA SBB12131407GA RT412101619GA RT412101640GA RT412101643GA SBB12131353GA SBB12131370GA SBB12131375GA SBB12131383GA SBB12131385GA SBB12131388GA SBB12131374GA SBB12131359GA SBB12131389GA RT412091503GA RT412101672GA RTW11366761GA RTW11446934GA SBB12131361GA SBB12131362GA SBB12131338GA RT412091493GA RT412091495GA SBB12020996GA SBB12031051GA SBB12041074GA SBB12041082GA SBB12041084GA SBB12041092GA SBB12041115GA SBB12041125GA SBB12051139GA SBB12051146GA SBB12051148GA SBB12051152GA SBB12061189GA SBB12061196GA SBB12061198GA SBB12061210GA SBB12061214GA SBB12061222GA SBB12071234GA SBB12071249GA SBB12071259GA SBB12071263GA SBB12071271GA SBB12111287GA SBB12111295GA SBB12111298GA SBB12111303GA SBB12111306GA SBB12111307GA SBB12121308GA SBB12121310GA SBB12121311GA SBB12121313GA SBB12121314GA SBB12121315GA SBB12121316GA SBB12121317GA SBB12121319GA SBB12121320GA SBB12121321GA SBB12131340GA SBB12131341GA SBB12131342GA SBB12131346GA SBB12131348GA SBB12131349GA SBB12131351GA SBB12131352GA SBB12131354GA SBB12131357GA SBB12131358GA SBB12131360GA SBB12131366GA SBB12131371GA SBB12131372GA SBB12131377GA SBB12131378GA SBB12131382GA SBB12131384GA SBB12131387GA SBB12131390GA SBB12131397GA SBB12131399GA SBB12131403GA SBB12131405GA RT412071428GA RT412081434GA RT412081439GA RT412081442GA RT412081445GA RT412081459GA RT412081464GA RT412081471GA RT412081480GA RT412091497GA RT412101577GA RT412081437GA RT412081473GA RT412081474GA RT412101568GA RT412101575GA RT412101579GA RT412101584GA RT412101589GA RT412101593GA SBB12131394GA RTW11346665GA RTW11346668GA RT412101581GA RT412081444GA RT412081476GA RT412081477GA RT412081479GA SBB12071244GA RT412081446GA RT412081447GA RT412091491GA SBB12071247GA SBB12071254GA RT412081451GA RT412081453GA RT412081454GA RT412081455GA RT412081458GA RT412081461GA RT412081467GA RT412081468GA RT412081478GA RT412081481GA SBB12061187GA SBB12061188GA SBB12061195GA SBB12071227GA SBB12071228GA SBB12071229GA SBB12071235GA SBB12071241GA SBB12071246GA SBB12071248GA SBB12071250GA SBB12071251GA SBB12071252GA SBB12071255GA SBB12071256GA RT412081433GA SBB12051151GA SBB12051155GA SBB12071231GA SBB12071232GA SBB12071236GA SBB12031037GA SBB12031038GA SBB12071240GA SBB12020993GA SBB12021011GA SBB12041068GA SBB12041071GA SBB12041087GA SBB12041110GA SBB12041114GA SBB12041119GA SBB12051149GA SBB12051150GA RT412081452GA SBB12031062GA SBB12041072GA SBB12041105GA SBB12041112GA SBB12051147GA SBB12051171GA SBB12051172GA SBB12051173GA SBB12051174GA SBB12051175GA SBB12051176GA SBB12051177GA SBB12051178GA SBB12051179GA SBB12051180GA SBB12051181GA SBB12051182GA SBB12051183GA SBB12051184GA SBB12051185GA SBB12061190GA SBB12061191GA SBB12061197GA SBB12061200GA SBB12061201GA SBB12061202GA SBB12061203GA SBB12061204GA SBB12061205GA SBB12061206GA SBB12061207GA SBB12061208GA SBB12061209GA RT412081430GA RT412081431GA RT412081432GA RT412081438GA RT412081443GA RT412081456GA RTW11346659GA RTW11346663GA RTW11346664GA SBB12020997GA SBB12021001GA SBB12031034GA SBB12031047GA SBB12031054GA SBB12031061GA SBB12041069GA SBB12041070GA SBB12041073GA SBB12041077GA SBB12041078GA SBB12041079GA SBB12041080GA SBB12041081GA SBB12041083GA SBB12041088GA SBB12041090GA SBB12041093GA SBB12041094GA SBB12041095GA SBB12041099GA SBB12041104GA SBB12041113GA SBB12041118GA SBB12041132GA SBB12051134GA SBB12051143GA SBB12051144GA SBB12051145GA SBB12051154GA SBB12051156GA SBB12041076GA SBB11440859GA SBB12041075GA SBB12051135GA SBB11410818GA SBB12041107GA SBB12041100GA RT412071425GA RT412071426GA RT412081466GA RT412071424GA RT412021415GA RT412071423GA RT412071427GA SBB12041102GA SBB12041127GA SBB12031035GA SBB12041122GA RT412011402GA SBB12041097GA SBB12041098GA SBB12041111GA RT412021412GA SBB12031056GA RTW11346605GA SBB12031040GA SBB12031042GA SBB12031044GA SBB12031045GA SBB12031049GA SBB12021002GA RT412021404GA RT412021405GA RT412021406GA RT412021407GA RT412021408GA RT412021409GA RT412021413GA RT412021414GA RT412021417GA RT412021418GA RT412021419GA SBB12031041GA RT412011392GA RT412011394GA RT412011395GA RT412011396GA RT411110344GA RT411110381GA RT411381067GA RT411381098GA RT412011393GA RT412011398GA RT412011399GA RT412011401GA SBB12020999GA SBB12021004GA SBB12031020GA SBB12020990GA SBB12020992GA SBB12020995GA SBB12021003GA RT411110382GA RT412011381GA RT412011384GA RT412011385GA RT412011386GA RT412011387GA RT412011389GA RT412011390GA RT412011391GA SBB10349892GA RT412011377GA RT412011379GA RT412011380GA RT411521366GA RT412011378GA RT411391202GA RT411401220GA RT411401222GA RT411401223GA RT411401224GA RT411401233GA RT411401236GA RT411401238GA RT411401239GA RT411401240GA RT411401241GA RT411411248GA RT411411253GA RT411411256GA RT411411262GA RT411411263GA RT411411268GA RT411411271GA RT411411272GA RT411411273GA RT411411274GA RT411411277GA RT411411281GA RT411411282GA RT411411285GA RT411411286GA RT411451293GA RT411451294GA RT411451298GA RT411511304GA RT411511305GA RT411511306GA RT411511308GA RT411511309GA RT411511313GA RT411511314GA RT411511315GA RT411511316GA RT411511317GA RT411511320GA RT411511321GA RT411511322GA RT411511323GA RT411511324GA 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SBB11490927GA SBB11490936GA SBB11490937GA SBB11500938GA SBB11500939GA SBB11510940GA SBB11510942GA SBB11510943GA SBB11510944GA SBB11510945GA SBB11510946GA SBB11510949GA SBB11510950GA SBB11510952GA RTW11316345GA RTW11346590GA RTW11346594GA SBB11490922GA SBB11490933GA SBB11510941GA RT411401204GA RT411401225GA RT411401235GA RT411401242GA RT411411249GA RT411411250GA RT411411252GA RT411411257GA RT411411258GA RT411411260GA RT411411265GA RT411451289GA RT411451290GA RT411451291GA RT411451292GA RT411451295GA RT411451296GA RT411451297GA RT411451299GA RT411451300GA RT411451301GA RT411451303GA RTW11346619GA SBB11490930GA SBB11490931GA SBB11490900GA SBB11490916GA SBB11490923GA SBB11490929GA SBB11490935GA SBB11490894GA SBB11490899GA SBB11490903GA SBB11490904GA SBB11490928GA SBB11490932GA SBB11490934GA SBB11490872GA SBB11490908GA RT411411278GA RT411411280GA RTW11346586GA SBB11490873GA SBB11490876GA SBB11450871GA SBB11410831GA SBB11440857GA SBB11440862GA SBB11440869GA SBB11490874GA SBB11490875GA SBB11170660GA SBB11170684GA SBB11170761GA SBB11390764GA SBB11390765GA SBB11390766GA SBB11390767GA SBB11390768GA SBB11390769GA SBB11390770GA SBB11390771GA SBB11390772GA SBB11390773GA SBB11390774GA SBB11390775GA SBB11390776GA SBB11390777GA SBB11390778GA RTW11346631GA SBB11110586GA SBB11110591GA SBB11110596GA SBB11170682GA RT411401231GA RT411401243GA RT411401244GA RT411411251GA RT411411264GA RT411411266GA RT411411267GA RT411411270GA RT411411284GA RT411401208GA SBB11410818GA SBB11440859GA SBB11410828GA SBB11410846GA SBB11410847GA RT411391175GA SBB11440867GA SBB11440868GA SBB11440870GA SBB11410830GA SBB11410845GA SBB11410853GA SBB11410813GA SBB11410844GA SBB11410841GA RT411401206GA SBB11410843GA SBB11410835GA RT411391157GA RT411391160GA RT411391162GA RT411210506GA RT411381085GA RT411381103GA RT411391145GA RT411391148GA RT411391149GA RT411391166GA RT411391170GA RT411391173GA RT411391185GA RT411391189GA RT411391197GA RT411391198GA RT411391199GA RT411391200GA SBB11400797GA SBB11400803GA SBB11400805GA SBB11410823GA SBB11050526GA SBB11050562GA SBB11060499GA SBB11400804GA SBB11390779GA SBB11390781GA SBB11390783GA SBB11390784GA SBB11390785GA RT411110339GAMKE RT411110341GA RT411110346GA RT411110352GA RT411110358GA RT411110361GA RT411110374GA RT411140396GA RT411170432GAMKE RT411170460GA RT411180477GA RT411180479GA RT411180480GA RT411180484GA RT411180485GAMKE RT411180488GAMKE RT411180489GA RT411210501GA RT411210503GA RT411210504GA RT411210505GA RT411210508GA RT411210509GA RT411210511GA RT411210514GA RT411210516GA RT411210517GA RT411210518GA RT411210520GA RT411210521GA RT411210524GA RT411210526GA RT411210529GA RT411210530GA RT411210531GA RT411210534GA RT411210535GA RT411210537GA RT411210539GA RT411210540GA RT411220546GA RT411220547GA RT411220548GA RT411220550GA RT411220551GA RT411220554GA RT411220566GA RT411220567GA RT411220568GA RT411220569GA RT411220571GA RT411220572GA RT411220573GA RT411220574GA RT411220575GA RT411220577GAMKE RT411220578GA RT411220579GA RT411220580GA RT411220583GA RT411240586GA RT411240587GA RT411240588GA RT411240589GA RT411240590GA…
Recall started: April 3, 2013
Device type: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Root cause (FDA): Nonconforming Material/Component
What the company told customers: GE Healthcare "Urgent Medical Device Correction" letter dated April 3, 2013 to all affected customers. The letter was addressed to Healthcare Administrator / Risk manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Product, Safety Instructions, Affected Product Details, and Product Correction. For questions contact Technical Support at 1-800-558-7044.
Recall number: Z-2117-2013

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

Source: FDA · Medical device enforcement reports, recall numbers Z-2115-2013, Z-2116-2013, Z-2117-2013. The agency record governs; check it and the company before acting.

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