FDA · Medical device recall

GE Healthcare… and 2 more products

Jan. 29, 2014 Class II

Date: Jan. 29, 2014
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: Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable connector on the DASH, PDM, and/or Tram Module. May result in reduced ECG, Respiration and arrhythmia detection performance.
Distribution pattern: Worldwide Distribution: US (nationwide) including DC and PR except SD, VT and WY; and Internationally to: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, EGYPT, GERMANY, UNITED KINGDOM, IRELAND, IRAQ, ISRAEL, JAMAICA, JAPAN, JORDAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MARITIUS, MALDOVA, NEW ZEALAND, NIGERIA, PAKISTAN, PANAMA, PARAGUAY, PERU, POLAND, QATAR, RUSSIA, SLOVAKIA, SOUTH AFRICA, SWEDEN, SWITZERLAND, TUNISIA, UNITED ARAB EMIRATES, VENEZUELA, CHILE, CANADA, and BERMUDA.

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. K073462: The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, free-standing surgical centers, and other alternate care facilities. Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, inoninvasive blood pressure, heart rate, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, bi-spectral index, impedance cardiography, oxygen, and anesthetic agents as summarized in the operators manual. The Dash 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORK indirectly to clinical information systems (via our Enterprise Gateway) and allow the user to access hospital data at the point-of-care. The information can be displayed, trended, stored, and printed. The Dash 3000/4000/5000 patient monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs. K992929: The Dash 3000 Patient Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash is designed as a bedside, portable, and transport monitor that can operate in all professional medical facilities and medical transport modes including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities, intra-hospital patient transport, inter-hospital patient transport via ground vehicles (i.e. ambulance, etc.) and fixed and rotary winged aircraft, and prehospital emergency response. Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, and carbon dioxide as summarized in the operators manual. The Dash 3000 Patient Monitoring System is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital data at the point-of-care. This information can be displayed, trended, stored, and printed.
Quantity: 47,125 (38,710 US, 8,415 OUS)
Codes and lots: Serial Number F1DJ2018G H9DJ0236G E1DJ0384G SBG06398779GA A3DJ4203G J2DJ8331G SBG06182479GA SBG06192680GA F2DJ5762G DSH04532005GA G1DJ2217G E2DJ3710G M3EH8966GR L0DJ5294G SBG05463469GA SBG06264541GA M2DJ2447G J3EH5175G L2DJ1220G B0DJ1561G SD007293609GA L2DJ1263G C1DJ8662G A4EH1258G F0DJ3308G SBG06046629GA SD007262789GA AAB04254355GA SD008429849GA B2DJ1915G DSH05293139GA SD008138223GA H9DJ0155GR SD007251995GA H1DJ3351G SBG06046550GA F2DJ5089G DSH05185989GA H2DJ7244G F1DJ1599G M1DJ7820G DSH05318073GA M2DJ3629G L1DJ6712GR D2DJ2937GR K0DJ5004GR SD007335572GA AAB04231070GA H2DJ7075G K1DJ5436G K1DJ4937G F1DJ1095G B0DJ1414G E2DJ3955G E2DJ4138GR F1DJ1219G A2DJ9815G SBG06451891GA A3DJ4322G SBG05514986GA DSH05318052GA C3DJ7072G H2DJ7154G G2DJ6587GR DSH05292993GA DSH04470444GA M2DJ2896G H9DJ0359G E1DJ0785G DSH05293010GA F0DJ3187G SBG06264685GA D0DJ2288G M9DJ1149G A2DJ9164G G0DJ3490G AAB04356778GA F0DJ3109GR SD007462511GA DSH05083862GA B1DJ7749G SD007451806GA SD010387765GA B2DJ9976G E1DJ1008G C1DJ8498G DSH05043084GA SBG05525493GA DSH05032811GA SD010117163GA SD009316807GA SBG06336410GA M2DJ2785G M2DJ1981G B2DJ1162GR SD007462383GA B4EH4615G DSH05358956GA G1DJ2480G K2DJ9527G DSH05328251GA SD007303935GA SD009389115GA E3DJ8843GR L3EH8132G AAB04190508GA D3DJ8386G SD008526318GA SD008294211GA E1DJ0742G K0DJ4668G L3EH8063G F1DJ1089GR SD007397737GA E3DJ8752G C1DJ8754G DSH05307981GA E3DJ9275G L1DJ6819G F0DJ3079G B3DJ5494G B4EH4576G SD008377628GA E2DJ3754G DSH05185950GA SD008515789GA D2DJ3339GR G2DJ6198G E1DJ0656G SBG06451791GA J0DJ4421G DSH05063506GA DSH05328266GA E2DJ3688G DSH05022478GA L2DJ1506G G2DJ6199G C2DJ1967G D0DJ2360G L1DJ6959G J3EH5899G H1DJ3337G SHQ12167194SA J1DJ4547G D2DJ3227G C1DJ8552G E2DJ3637G AAB04377453GA AAB04264700GA J2DJ8391G SHQ12402047SA SD010251247GA L3EH7800GR E1DJ0720G F0DJ2863G AAB04377323GA L0DJ5701G H2DJ7092G F2DJ6031G M2DJ3100GR SD007252034GA AAB04139260GA AAB04160036GA AAB04160038GA AAB04160040GA AAB04160042GA AAB04160044GA AAB04160048GA AAB04160048GR AAB04160049GA AAB04160079GA AAB04160080GA AAB04160082GA AAB04180103GA AAB04180117GA AAB04180121GA AAB04180123GA AAB04180124GA AAB04180126GA AAB04180127GA AAB04180128GA AAB04180129GA AAB04180130GA AAB04180137GA AAB04180138GA AAB04180141GA AAB04180165GA AAB04180166GA AAB04180167GA AAB04180168GA AAB04180169GA AAB04180184GR AAB04180186GA AAB04180188GA AAB04180190GA AAB04180191GA AAB04180192GA AAB04180211GA AAB04180212GA AAB04180213GA AAB04180218GA AAB04180218GR AAB04180219GA AAB04180250GA AAB04180251GR AAB04180259GA AAB04180260GA AAB04180261GR AAB04180262GA AAB04180278GR AAB04180283GA AAB04180284GA AAB04180285GA AAB04190302GA AAB04190307GA AAB04190312GA AAB04190313GA AAB04190314GA AAB04190316GA AAB04190318GA AAB04190319GR AAB04190322GA AAB04190325GA AAB04190333GA AAB04190335GA AAB04190337GA AAB04190339GA AAB04190344GA AAB041903479GA AAB04190352GA AAB04190353GA AAB04190354GA AAB04190376GA AAB04190378GA AAB04190379GA AAB04190383GA AAB04190384GA AAB04190388GA AAB04190389GA AAB04190394GA AAB04190398GA AAB04190402GA AAB04190436GA AAB04190437GA AAB04190438GA AAB04190439GA AAB04190454GA AAB04190467GA AAB04190468GA AAB04190473GA AAB04190482GA AAB04190483GA AAB04190484GA AAB04190485GA AAB04190486GA AAB04190487GA AAB04190488GA AAB04190495GA AAB04190496GA AAB04190497GA AAB04190498GA AAB04190500GA AAB04190501GA AAB04190501GR AAB04190504GA AAB04190504GR AAB04190505GA AAB04190506GA AAB04190509GA AAB04190510GA AAB04190512GR AAB04190515GA AAB04190516GA AAB04190517GA AAB04190527GA AAB04190528GA AAB04190529GA AAB04190530GA AAB04190531GA AAB04190539GA AAB04190541GA AAB04190545GA AAB04190546GA AAB04190548GA AAB04190549GA AAB04190551GA AAB04190552GA AAB04190553GA AAB04190555GA AAB04190570GA AAB04190571GA AAB04190573GA AAB04190578GA AAB04190579GA AAB04190582GA AAB04190584GR AAB04190593GA AAB04190594GA AAB04190599GR AAB04210614GA AAB04210620GA AAB04210621GA AAB04210622GA J3EH5816G AAB04210630GA AAB04210633GA AAB04210635GA AAB04210640GA AAB04210642GA AAB04210643GA AAB04210644GA AAB04210645GA AAB04210648GR AAB04210656GA AAB04210678GA SD010365982GA AAB04210689GA AAB04210690GA AAB04210698GA AAB04210705GA AAB04210706GA AAB04210707GA AAB04210709GA AAB04210710GA SD010365983GA AAB04210716GA AAB04210719GA AAB04210720GA AAB04210722GA AAB04210728GR AAB04210738GA AAB04210741GA AAB04210747GA AAB04210753GA AAB04210763GA AAB04210765GA AAB04210767GA AAB04210770GA AAB04210772GA AAB04210773GA AAB04210775GA AAB04210779GA AAB04210785GA AAB04210789GA AAB04210790GA AAB04210791GA AAB04210793GA AAB04210794GA AAB04210795GA AAB04210796GA AAB04210805GA AAB04210806GA AAB04210813GA AAB04210821GA AAB04210822GA AAB04210823GA AAB04210824GA AAB04210826GA AAB04210827GA AAB04210830GA AAB04210835GA AAB04210836GA AAB04210839GA AAB04210842GR AAB04210845GA AAB04210847GA AAB04210849GA AAB04210850GA AAB04210851GA AAB04210853GA AAB04210854GA AAB04210856GA AAB04210859GA AAB04220860GA AAB04220867GA AAB04220870GA AAB04220879GA AAB04220881GA AAB04220882GA AAB04220883GA AAB04220884GA DSH04450132GA DSH04490862GA AAB04220896GA AAB04220900GA AAB04220901GA AAB04220902GA AAB04220903GA AAB04220904GA G3EH3483G AAB04220909GA AAB04220920GA AAB04220923GA AAB04220926GA AAB04220932GA AAB04220954GA H3EH4700G AAB04220972GA AAB04220973GA AAB04220974GA AAB04220978GA AAB04220984GA AAB04220985GA AAB04220986GA AAB04220988GA AAB04220993GA AAB04220995GA AAB04220996GA AAB04221004GA AAB04221005GA AAB04221008GA H3EH4789G J3EH5392G AAB04221015GA E3DJ9160G M3EH9378G D1DJ9619GR D3DJ7814GR J2DJ8761GR C1DJ9040GR AAB04221031GA AAB04221032GA AAB04221033GA AAB04231041GA AAB04231042GA AAB04231045GA AAB04231047GA AAB04231057GA AAB04231058GA AAB04231059GA AAB04231060GA AAB04231061GA D1DJ9601GR AAB04231067GA AAB04231068GA AAB04231069GA AAB04231071GA AAB04231072GA AAB04231086GA AAB04231087GA AAB04231088GA AAB04231089GA AAB04233691GA AAB04233723GA AAB04233724GA D2DJ3282GR AAB04233727GA AAB04233735GA AAB04233736GA AAB04233746GA AAB04233759GA AAB04233770GA AAB04233772GA AAB04233773GA AAB04233776GA AAB04233778GA AAB04233780GA AAB04233781GA AAB04233784GA AAB04233812GA AAB04233820GA AAB04233824GA AAB04233828GA AAB04233829GA AAB04233830GA AAB04233836GA AAB04233840GA AAB04233841GA AAB04233855GA AAB04233857GA AAB04233858GA AAB04233862GA AAB04233869GA AAB04243890GA AAB04243899GA AAB04243900GA AAB04243902GA AAB04243906GA AAB04243908GA AAB04243909GA AAB04243919GA AAB04243923GA AAB04243924GA AAB04243925GA AAB04243928GA AAB04243929GA AAB04243930GA AAB04243931GA AAB04243947GA AAB04243952GA AAB04243956GA L1DJ6680GR AAB04243984GA AAB04243985GA AAB04243986GA AAB04243988GA AAB04244017GA AAB04244018GA AAB04244020GA AAB04244021GA AAB04244024GA AAB04244027GA AAB04244044GA AAB04244067GA AAB04244068GA AAB04244069GA AAB04244070GA AAB04244087GA AAB04244088GA AAB04244089GA AAB04244090GA AAB04244092GA AAB04244094GA AAB04244095GA AAB04244096GA AAB04244106GA AAB04244109GA AAB04244110GA AAB04244114GA AAB04244116GA AAB04244117GA AAB04244120GA A4EH3739G AAB04244125GA AAB04244126GA AAB04244140GA AAB04244150GA AAB04244151GA AAB04244152GA AAB04244165GA AAB04244167GA AAB04244174GA AAB04244187GA AAB04244189GA AAB04244194GR AAB04244813GA C4EH6080G AAB04254222GA AAB04254229GA AAB04254233GA AAB04254234GA AAB04254235GA AAB04254236GA AAB04254237GA AAB04254244GR AAB04254259GA AAB04254260GA AAB04254267GA AAB04254268GA AAB04254269GA AAB04254271GA AAB04254272GA AAB04254274GA AAB04254275GA AAB04254276GA AAB04254277GA AAB04254278GA AAB04254279GA AAB04254280GA AAB04254285GA AAB04254286GA AAB04254289GA AAB04254299GA AAB04254300GA AAB04254301GA AAB04254302GA AAB04254305GA AAB04254306GA AAB04254308GA D4EH6416G AAB04254318GA AAB04254319GA AAB04254320GA AAB04254321GA AAB04254322GA AAB04254326GA AAB04254335GA AAB04254356GA AAB04254357GA AAB04254358GA AAB04254360GA AAB04254361GA AAB04254362GA AAB04254363GA AAB04254364GA AAB04254370GA AAB04254374GA AAB04254375GA AAB04254377GA AAB04254383GA C0DJ1912G AAB04254388GA AAB04254389GA AAB04254390GA C0DJ1974G C0DJ1976G AAB04254399GR AAB04254401GR AAB04254403GA AAB04254405GA AAB04254406GA AAB04254408GA AAB04254409GA AAB04254410GA AAB04254415GA AAB04254416GA AAB04254420GA AAB04254421GA AAB04254422GA AAB04254423GA AAB04254424GA AAB04254425GA AAB04254426GA AAB04254427GA AAB04254428GA AAB04254429GA AAB04254432GA AAB04254433GA AAB04254437GA AAB04254440GA AAB04254441GA AAB04254442GA AAB04254443GA AAB04254446GA AAB04254449GA AAB04254450GA AAB04254452GA AAB04254453GA AAB04254455GA AAB04254456GA AAB04254457GA AAB04254459GA AAB04254460GA AAB04254468GA AAB04254469GA AAB04254470GA AAB04254473GA AAB04254474GA AAB04254475GA AAB04254476GA AAB04254477GA D0DJ2404G AAB04254483GA AAB04254484GA F0DJ3209G AAB04254486GA AAB04254487GA AAB04254488GA AAB04254489GA AAB04254490GA AAB04254491GA AAB04254492GA AAB04254493GA J0DJ4272G J0DJ4273G AAB04254496GA J0DJ4280G AAB04254498GA AAB04254499GA J0DJ4282G AAB04254507GA AAB04254508GA AAB04254509GA AAB04254510GA AAB04254511GA AAB04254512GA AAB04254534GA AAB04254540GA J0DJ4287G J0DJ4288G AAB04254547GA AAB04254549GA AAB04254550GA AAB04254553GA AAB04254556GA AAB04254560GA AAB04254561GA AAB04264564GA AAB04264567GA AAB04264573GA AAB04264574GA AAB04264577GA AAB04264578GA AAB04264582GA AAB04264585GA J0DJ4379G J0DJ4418G AAB04264591GA AAB04264600GA AAB04264603GA AAB04264604GA AAB04264606GA AAB04264607GA AAB04264612GA AAB04264613GA AAB04264616GA AAB04264619GA J0DJ4425G J0DJ4444G K0DJ4912G AAB04264623GA AAB04264624GA AAB04264625GA AAB04264626GR AAB04264627GR AAB04264628GR AAB04264632GA AAB04264641GA AAB04264647GA AAB04264647GR AAB04264653GA K1DJ4878G SBG06046491GA SBG06046492GA SBG06046549GA AAB04264659GA SBG06046618GA D1DJ9613GR AAB04264662GA AAB04264665GA AAB04264666GA AAB04264668GA AAB04264669GA AAB04264670GA AAB04264671GA AAB04264672GA AAB04264682GA AAB04264683GA AAB04264684GA AAB04264685GA AAB04264686GA AAB04264688GA AAB04264693GA AAB04264694GA AAB04264697GA AAB04264703GA AAB04264705GA D1DJ9628GR AAB04264713GA AAB04264714GA AAB04264723GA AAB04264727GA AAB04264728GA AAB04264729GR AAB04264731GA AAB04264736GA AAB04264738GA AAB04264739GA AAB04264740GA AAB04264750GA AAB04264751GA AAB04264752GA AAB04264753GA AAB04264756GA AAB04264757GA AAB04264758GA AAB04264759GA AAB04264760GA AAB04264761GA AAB04264762GA AAB04264763GA AAB04264764GA AAB04264767GA AAB04264768GA AAB04264770GA AAB04264779GA AAB04264781GA AAB04264782GA AAB04264783GA AAB04264784GA AAB04264785GA AAB04264789GA AAB04264790GA AAB04264791GA AAB04264792GA AAB04264793GA AAB04264794GA AAB04264795GA AAB04264796GA AAB04264799GA AAB04264800GA AAB04264801GA AAB04264803GA AAB04264813GA AAB04264814GA AAB04264816GA AAB04264817GA AAB04264819GA AAB04264823GA AAB04264825GA AAB04264827GA AAB04264828GA AAB04264829GA AAB04264830GA AAB04264831GA AAB04264832GA AAB04264834GA AAB04264840GA AAB04264841GA D2DJ3115GR AAB04264843GA AAB04264844GA AAB04264849GA AAB04264853GA AAB04264854GA AAB04264855GA D2DJ3288GR AAB04264857GA AAB04264860GA AAB04264862GA AAB04264863GA AAB04264864GA AAB04264866GA AAB04264869GA AAB04264872GA AAB04264879GA AAB04264880GA AAB04264881GA AAB04264882GA AAB04264883GA AAB04264884GA AAB04264885GA H2DJ8212GR AAB04264888GA AAB04264889GA AAB04264890GA AAB04264891GA AAB04264893GA AAB04264894GA AAB04264895GA AAB04264896GA AAB04264897GA AAB04264899GA AAB04264901GA AAB04264902GA AAB04264907GA AAB04264909GA J1DJ4122GR L1DJ6750GR AAB04264912GA M2DJ3085GR M2DJ3223GR M2DJ3227GR AAB04264922GA M2DJ3230GR AAB04264926GA AAB04264928GA AAB04264929GA AAB04264930GA AAB04264933GA AAB04264937GA AAB04264940GA AAB04264941GA AAB04264943GA AAB04264944GA AAB04264947GA AAB04264949GA AAB04264950GA AAB04264952GA AAB04264960GA AAB04264961GA M2DJ3400GR F3EH0944G AAB04274978GA AAB04274979GA AAB04274980GA AAB04274981GA H3EH4336G AAB04275003GA AAB04275006GA AAB04275011GR AAB04275015GA AAB04275016GA AAB04275021GA J3EH5873G AAB04275064GA AAB04275067GA AAB04275070GA AAB04275074GA AAB04275075GA AAB04275086GA AAB04275087GA AAB04275089GA AAB04275099GR L3EH7819G AAB04275119GA AAB04275122GA AAB04275124GA L3EH8047G L3EH8247G AAB04275132GA AAB04275134GA AAB04275135GA AAB04275136GA AAB04275137GA AAB04275141GA AAB04275142GA…
Recall started: Dec. 5, 2013
Device type: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Root cause (FDA): Pending
What the company told customers: GE Healthcare sent an Urgent Medical Device Correction letter dated December 5, 2013, to all affected customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Customers with questions were instructed to contact Technical Support at 1-800-558-7044. For questions regarding this recall call 262-513-4122.
Recall number: Z-0806-2014

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. The Solar 8000i with Patient Data Module/Transport Pro with Patient Data Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional medical facility, such as hospital, clinic, surgical center or doctors office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), chest pain clinic, general intensive care unit (ICU), critical care unit, surgical intensive care unit (SICU), respiratory intensive care unit, coronary care unit (CCU), medical intensive care unit (MICU), pediatric intensive care unit (PICU), or neonatal intensive care unit (NICU). 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. Physiological parameter data acquired by the PDM includes ECG, invasive pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output nad respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes. The Transport Pro patient monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. When used with the Patient Data Module (PDM) or the TRAM acquisition module, this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult, pediatric, and neonatal patients during transport from one area of the healthcare facility to another. Physiological parameter data includes ECG, invasive pressure, noninvasive blood pressure, pulse oximetry, temperature and respiration. Both the PDM and TRAM acquisition module acquire, process and store information for all aforementioned parameters. The Solar 8000i patient monitoring system is a multi-parameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients. It provides uninterrupted monitoring of physiological patient data. The Solar 8000i patient monitoring system is capable of monitoring and analyzing the following parameters for all patient populations: Electrocardiogram, invasive pressure, non-invasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, venous oxygen saturation, transcutaneous pO2 and pCO2, CO2 and respiratory mechanics. The Solar 8000i patient monitoring system is capable of GE Healthcare Page 3 of 6 monitoring the following parameters for adult and pediatric patient populations: anesthetic agent concentrations, O2, impedance cardiography, electroencephalography and bispectral index. The Solar 8000i patient monitoring system interfaces with a variety of third-party peripheral medical devices that support serial and /or analog data outputs. Information from these devices can be displayed, trended and stored in the monitoring system. The solar 8000i patient monitoring system also provides physiological data over the Unity Network.
Quantity: 2516 (2,321 US, 195 OUS)
Codes and lots: Serial Number SA308044521GR SA308186360GA SA310444859GA SA308186380GA SA312091241GA SA308491207GA SA308186401GA SA308186385GA SA308186374GA SA308155957GA SA308186391GA SA308186366GA SA308186410GA SA308094871GA SA308094818GA SA308186445GA SA308186381GA SA312479810GA SA308094940GA SA308094803GA SA308094872GA SA308084770GA SA310528992GA SA310506733GA SA310506696GA SA311153223GA SA311142931GA SA312080647GA SA312080894GA SA308186396GA SA308166121GA SA308186397GA SA308094807GA SA308186404GA SA311153169GA SA308186377GA SA308398894GA SA312253398GA SA308094809GA SA309263954GA SA310048616GA SA309527962GA SA310038386GA SA310048604GA SA310048613GA SA310028273GA SA310038462GA SA308317172GA SA311184814GA SA309365237GR SA311142946GA SA307332233GA SA307231341GA SA312069693GA SA309456714GA SA311163858GA SA312049242GA SA311317628GA SA307423146GA SA310259886GA SA309142960GA SA309334557GA SA307393020GA SA307453540GA SA307210827GA SA312018863GA SA307241567GA SA311163574GA SA312039090GA 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SA311184580GA SA311184555GA SA310139045GA SA309122626GA SA311184775GA SA310219791GA SA311327933GA SA311132276GA SA308368065GA SA310372059GA SA309334560GA SA312069651GA SA312029022GA SA311122215GA SA311307560GA SA311428082GA SA309355014GA SA311060295GR SA308266845GA SA311174196GA SA311090932GA SA311090941GA SA308459749GA SA311307556GA SA311163718GA SA312080707GA SA308388614GA SA311317638GA SA312070158GA SA311337974GA SA312080624GA SA312080631GA SA312080561GA SA309243678GA SA309193357GA SA309334577GA SA309334566GA SA309334562GA SA309324425GA SA309334650GA SA309334597GA SA309243697GA SA309243693GA SA309243687GA SA309243686GA SA309243685GA SA309193346GA SA309193331GA SA309193329GA SA309446534GA SA311317648GA SA310475634GA SA312080874GA SA312080701GA SA312121711GA SA312049469GA SA309233520GA SA312080824GA SA311518705GA SA312355402GA SA311428161GA SA312029016GA SA308286922GA SA309538046GA SA309334575GA SA309334664GA SA309193343GA SA308155975GA SA312152331GA SA309193362GA SA309324321GA SA309324317GA SA309294071GA SA309294053GA SA309243680GA SA309193336GA SA309193318GA SA309193312GA SA312049463GA SA312049457GA SA311060218GA SA307504201GA SA312070182GA SA307140631GA SA312090928GA SA312101445GA SA311174194GA SA308327455GA SA309243679GA SA309243677GA SA309203393GA SA309334563GA SA309324445GA SA309324437GA SA309334721GA SA309334604GA SA309294028GA SA309334587GA SA309243689GA SA309243684GA SA309193352GA SA308095013GA SA310496469GA SA312121928GA SA309324438GA SA309334598GA SA311428097GA SA312069863GA SA310361762GA SA311428127GA SA312111487GA SA312121926GA SA309334591GA SA309477022GR SA309304234GA SA312152408GA SA310219829GA SA312121902GA SA311184728GA SA312091197GA SA311518716GA SA307332213GA SA311090787GA SA310372063GA SA311307542GA SA312091207GA SA307483808GA SA310372204GA SA310424046GA SA312091201GA SA307493994GA SA312080779GA SA312080769GA SA312080556GA SA312080763GA SA312080690GA SA312080596GA SA312080608GA SA312080797GA SA309334574GA SA309324413GA SA309294090GA SA309294058GA SA309294050GA SA309334596GA SA309334593GA SA309334592GA SA309294029GA SA309253840GA SA312091037GA SA308491186GA SA312028916GA SA309324443GA SA309334701GA SA309334652GA SA311174208GA SA309243682GA SA308166162GA SA311256789GA SA310485804GA SA310393011GA SA310259875GA SA309334621GA SA312059519GA SA311184867GA SA312091335GA SA308317185GA SA307140637GA SA311256730GA SA312049317GA SA311184757GA SA311174007GA SA311256832GA SA308145749GA SA310260055GA SA311287093GA SA311256751GA SA309385605GA SA311111641GA SA312069713GA SA309334564GA SA309193337GA SA310361764GA SA312111513GA SA308459822GA SA308409076GA SA312070304GA SA312079968GA SA309243669GA SA309193356GA SA309334571GA SA309334569GA SA309334561GA SA309324442GA SA309294089GA SA309294067GA SA309294061GA SA309294060GA SA309334665GA SA309334642GA SA309294057GA SA309294051GA SA309294047GA SA309334588GA SA309253750GA SA309334579GA SA309193339GA SA309324394GA SA309334753GA SA309334747GA SA309334713GA SA309334705GA SA309294068GA SA309294065GA SA309294055GA SA309263943GA SA309253909GA SA309253715GA SA309334583GA SA311428007GA SA312069714GA SA311307552GA SA311307549GA SA311246592GA SA311327846GA SA311307493GA SA311307466GA SA311317640GA SA311297246GA SA311327930GA SA311307499GA SA312091286GA SA312192705GA SA312253361GA SA307241684GA SA307443387GA SA309132846GA SA307210819GR SA312029046GA SA311337982GA SA311297337GA SA312080659GA SA312080783GA SA312080708GA SA312253104GA SA311287153GA SA312091196GA SA311428076GA SA311297378GA SA312080901GA SA311184499GA SA308501276GA SA310028197GA SA311205464GA SA308084662GA SA308084646GA SA310507326GA SA311060119GA SA311195041GA SA310260047GA SA312080558GA SA312080542GA SA312080744GA SA312080695GA SA311090765GA SA311205445GA SA311060302GA SA308084652GA SA308084664GA SA312090970GA SA311070537GA SA312049356GA SA311287066GA SA311163416GA SA311070574GA SA311070588GA SA311060141GA SA311070542GA SA308155857GA SA308084619GA SA308084653GA SA312018824GA SA312070164GA SA312070206GA SA312070377GA SA312070366GA SA312070141GA SA312070301GA SA310139188GA SA311327902GA SA311327922GA SA312029043GA SA310028187GA SA311060150GA SA311060158GA SA311060296GA SA311069729GA SA311528738GA SA311070593GA SA311060182GA SA312069653GA SA310028291GA SA312029056GA SA311060285GA SA308094965GA SA311090854GA SA308459790GA SA311246507GA SA311090762GA SA311101184GA SA311101217GA SA311060206GA SA311069714GA SA311060139GA SA311060124GA SA311070523GA SA311101285GA SA311060199GA SA311060278GA SA311060176GA SA311060152GA SA308084658GA SA308084612GA SA310455264GA SA308429334GA SA311428016GA SA310219844GA SA312090934GA SA311194883GA SA312080570GA SA309223484GA SA311205357GA SA311142721GA SA308317134GA SA308286913GA SA311317606GA SA311428010GA SA311194914GA SA311122125GA SA311317729GA SA310423962GA SA312039098GA SA311428049GA SA308398752GA SA308398756GA SA308317189GA SA311307597GA SA311059603GA SA310290660GA SA311090901GA SA312070233GA SA312070380GA SA312070378GA SA312090921GA SA312091011GA SA312070334GA SA312059533GA SA311297340GA SA312070294GA SA311297395GA SA311297383GA SA311256855GA SA311256734GA SA308501408GA SA308266821GA SA312070034GA SA311195239GA SA311194908GA SA311194945GA SA312263785GA SA310507387GA SA310455228GA SA310455227GA SA312111486GA SA309011850GA SA312070367GA SA312070211GA SA310382552GA SA311256815GA SA310507201GA SA311297407GA SA310507379GA SA310260009GA SA310118970GA SA311184745GA SA311317629GA SA311184878GA SA312029002GA SA311121817GA SA308491227GA SA311297301GA SA310199713GA SA310199589GA SA311327926GA SA311338002GA SA311297223GA SA311297370GA SA310382584GA SA308074605GA SA310199704GA SA310260007GA SA310199595GA SA310260021GA SA310260027GA SA310260001GA SA310260082GA SA310139260GA SA308378261GA SA310454928GA SA311101068GA SA311317635GA SA311307543GA SA311297376GA SA311297405GA SA310260006GA SA310260067GA SA310259975GA SA312079934GA SA309446464GA SA312090978GA SA309375473GR SA310518711GA SA308398721GA SA310199650GA SA310260017GA SA310260079GA SA310199664GA SA310199655GA SA310260049GA SA310199752GA SA312070297GA SA312070236GA…
Recall started: Dec. 5, 2013
Device type: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Root cause (FDA): Pending
What the company told customers: GE Healthcare sent an Urgent Medical Device Correction letter dated December 5, 2013, to all affected customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Customers with questions were instructed to contact Technical Support at 1-800-558-7044. For questions regarding this recall call 262-513-4122.
Recall number: Z-0807-2014

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. K900540: TRAM modules are intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The intended use of TRAM modules is 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. The TRAM module functions as a transport monitor during transport, and in the bedside monitor during ICU or OR monitoring. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature, and respiration. TRAM modules acquire, process and store information regarding these parameters. TRAM modules incorporate different monitoring capabilities based on their configuration. K011000: The TRAM 2001 Module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The TRAM 2001 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. During non-transport monitoring, the TRAM 2001 Module functions in the bedside monitoring system. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature, and respiration. The TRAM 2001 Module acquires, processes and stores information regarding these parameters. The device is intended for use in a professional medical facility, such as hospital, clinic, surgical center or doctors office. The TRAM System can be used in multiple areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. The device is intended for use as part of a transport monitoring system for intra-hospital transport. K053121: The TRAM Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in its proper use. 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. During non-transport monitoring, the TRAM Module functions in the bedside monitoring system. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and respiration. The TRAM Module acquires, processes and stores information regarding these parameters. The device is intended for use in a professional medical facility, such as hospital, clinic, surgical center or doctors office. The TRAM System can be used in multiple areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, pediatric intensive care, or neonatal intensive care. The device is intended for use as part of a transport monitoring system for intra-hospital transport.
Quantity: 1,948 (1,834 US; 114 OUS)
Codes and lots: Serial Number C7HA1686G C7HA1700G C7HA1701G C7HA1696G C7HA1692G C7HA1688G C7HA1691G C7HA1689G C7HA1687G C7HA1702G B7HA1657G C7HA1683G C7HA1703G C7HA1707G C7HA1709G C7HA1711G D8HA3141G D8HA3154G D8HA3135G D8HA3136G D8HA3149G D8HA3148G D8HA3128G D8HA3134G D8HA3152G D8HA3140G D8HA3137G D8HA3144G H3S20070G H3S20072G J3S20073G J3S20075G J3S20078G J3S20084G J3S20089G J3S20090G J3S20093G J3S20085G A4S20482G A4S20471G G4S21111G G4S21108G G4S21112G G4S21090G G4S21106G F5HB0489G E5HB0418G F5HB0493G F5HB0491G F5HB0468G F5HB0497G F5HB0478G E5HB0459G C5HB0346G B5HB0261G A6HB0980G A6HB0978G D6HB1379G K7HB4546G K7HB4542G K7HB4552G K7HB4553G K7HB4547G K7HB4556G C8HB5556G C8HB5743G C8HB5744G C8HB5758G C8HB5747G C8HB5746G C8HB5750G C8HB5756G C8HB5757G C8HB5676G D8HB5922G G8HB6864G G8HB6859G B9HA4387G B9HA4403G B9HA4405G B9HA4402G F8HB6464G L4HB0063G L4HB0068G L4HB0064G M4HB0151G M4HB0143G A5HA0120G A5HA0118G A5HA0125G A5HA0122G A5HA0112G A5HA0117G A5HA0111G A5HA0119G A5HA0109G A5HA0114G A5HA0124G L4HC0003G H5HA0362G H5HA0367G D6HB1475G D6HB1467G D6HB1455G D6HB1458G D6HB1442G D6HB1469G D6HB1430G D6HB1465G D6HB1435G D6HB1476G D6HB1440G D6HB1463G D6HB1439G D6HB1438G D6HB1461G D6HB1460G M6HD8751F M6HD8723F M6HD8732F M6HD8683F M6HD8749F M6HD8725F M6HD8748F M6HD8728F M6HD8737F M6HD8730F M6HD8750F M6HD8726F M6HD8747F M6HD8724F M6HD8736F M6HD8744F M6HD8740F M6HD8731F M6HD8745F M6HD8722F M6HD8739F M6HD8741F M6HD8742F M6HD8738F M6HD8746F A7HA1527G A7HA1564G A7HA1550G A7HA1546G A7HA1562G A7HA1529G A7HA1561G A7HA1563G A7HA1560G B7HA1598G B7HA1595G B7HA1583G B7HA1579G B7HA1591G B7HB2686G B7HB2694G B7HB2676G F7HB3564G F7HB3571G F7HB3561G F7HB3567G F7HB3499G F7HB3498G F7HB3526G F7HB3511G F7HB3516G F7HB3536G F7HB3537G F7HB3538G F7HB3541G F7HB3534G F7HB3533G F7HB3539G F7HB3532G F7HB3535G F7HB3548G F7HB3540G F7HB3589G F7HB3556G G7HB3740G G7HB3773G G7HB3772G G7HB3774G G7HB3747G G7HB3769G G7HB3775G G7HB3748G G7HB3766G G7HB3746G G7HB3735G G7HB3741G G7HB3726G H7HB4010G C8HB5492G C8HB5488G C8HB5481G C8HB5480G C8HB5493G C8HB5476G C8HB5508G C8HB5485G C8HB5482G C8HB5449G C8HB5484G C8HB5475G C8HB5490G C8HB5512G C8HB5491G C8HB5474G C8HB5453G C8HB5459G C8HB5456G M8HB8682G M8HB8677G A9HB8818G A9HB8832G M8HB8756G A9HB8806G A9HB8802G A9HB8824G A9HB8817G A9HB8809G M8HC0420G M8HC0427G M8HC0413G M8HC0422G M8HC0430G M8HC0414G M8HC0419G M8HC0416G M8HC0424G M8HC0417G M8HC0418G M8HC0423G M8HC0425G M8HC0415G M8HC0421G M8HC0428G M8HC0426G A9HC0432G A9HC0433G A9HC0436G A9HC0435G A9HC0446G A9HC0439G A9HC0451G A9HC0437G A9HC0440G A9HC0434G A9HC0447G A9HC0444G C9HB9411G C9HB9415G C9HB9445G C9HB9419G C9HB9298G C9HB9323G B9HB9240G C9HB9549G C9HB9563G C9HB9326G C9HB9322G C9HB9366G C9HB9439G C9HB9452G C9HB9451G C9HB9447G C9HB9450G C9HB9530G A8HB5120G RT405523022GA SBB06251137GA D2TW2498G RTW07332120GA L2T14637G A2TW1861G J2T14014G SBB06523641GA D3T42441G A4T19101G RT105433210GA K1T10362G M1TW1346G SBT06180805GA RT106044903GA RT106044763GA RT410139269GA SBB11440867GA SBB09488690GA A0HD3119F E0HD3395F E0HD3397F K0HD3752F K0HD3759F K0HD3762F K1HD4284F K1HD4291F E8HA3281GR M8HA4222GR G9HA5212G F9HA5071G F9HA5059G F9HA5134G C9HA4702G F9HA5131G G9HA5268G G9HA5265G G9HA5262G F9HA5145G K9HB1855G K0HA7181G K0HA7178G K0HA7182G K0HA7189G K0HA7173G K0HA7167G J0HA7192G J0HA7195G L0HA7794G L0HA7818G L0HA7815G L0HA7804G H9HB0934GR L9HB2176GR D0HB4296G C0HB4122GR D9HB9695G F9HB0324G F9HB0497G E0HB4448G E0HB4502G E0HB4547G E0HB4604G E0HB4616G E0HB4680G E0HB4687G E0HB4819G E0HB4881G F0HB5010G D0HC0713G J0HB5841G J0HB5865G J0HB5975G M0HB6696G M0HB6711G M0HB6760G M0HB6922G M0HB6925G M0HB6950G M0HB6953G M0HB6971G M0HB6973G M0HB6974G M0HB6976G M0HB6977G M0HB6979G M0HB6980G M0HB6982G M0HB6983G M0HB6986G M0HB6989G M0HB6990G M0HB6994G M0HB6995G M0HB6996G M0HB6999G M0HB7000G M0HB7001G M0HB7002G M0HB7006G M0HB6968G M0HB6988G M0HB6991G M0HB7010G M0HB7011G M0HB7012G M0HB7013G M0HB7015G M0HB7016G M0HB7017G M0HB7018G M0HB7019G M0HB7020G M0HB7023G M0HB7024G M0HB7025G M0HB7026G M0HB7028G M0HB7029G A1HB7547G A1HB7598G A1HB7601G A1HB7604G M0HB6970G C1HB8191G C1HB8220G C1HB8224G H1HB9502G H1HB9503G H1HB9504G H1HB9513G J9HB1067GR J9HB1245GR M9HB2825GR M9HB2899GR A0HB3179GR A0HB3216GR C0HA6610G C0HA6649G C0HA6503G C0HA6510G J0HB5995G K0HB6241G K0HB6275G K0HB6301G B1HB7863G C1HB8082G C1HB8088G C1HB8092G C1HB8107G C1HB8108G C1HB8136G C1HB8137G C1HB8147G C1HB8156G C1HB8162G C1HB8163G C1HB8170G C1HB8175G C1HB8176G C1HB8178G C1HB8210G C1HB8219G C1HB8230G D1HB8610G D1HB8632G H1HD4215F RT405160722GA RT407206340GA RT407206403GA RT407226441GA SCS07171073GA SCS07171078GA SCS07140998GA RT407266610GA SCS07461977GA RT407487540GA RT407517574GA RT407517605GA RT407517619GA RT408027651GA RT408298081GA RT408298094GA RT408338100GA RT408338106GA RT408338108GA RT408338115GA RT408338118GA RT408338122GA RT408338129GA RT408338131GA RT408338141GA RT408358146GA RT408358150GA RT408358151GA RT408358153GA RT408358154GA RT408418385GA RT408418423GA RT408438511GA RT408438512GA RT408438542GA RT408478600GA RT408478648GA RT408468610GA RT408478606GA SCS09464285GA SCS09464300GA RST10331659GA RST10331672GA SCS10415184GA B3T15631G D3T16359G D4T19517G D4T19634G D4T19637G D4T19638G RT105392851GA RT105392872GA RT105392880GA RT106034493GA RT106034498GA RT106024368GA RT106034464GA RT106034486GA RT106034488GA RT106034490GA RT106034492GA RT106034496GA RT106034518GA RT106044521GA RT106044537GA RT106044540GA RT106044541GA RT106044545GA RT106044546GA RT106044549GA RT106044551GA RT106044552GA RT106044553GA RT106044555GA RT106044556GA RT106044599GA RT106044600GA RT106044606GA RT106044653GA RT106044656GA RT106044657GA RT106044659GA RT106044660GA SBB06140254GA SBB06140258GA SBB06140262GA SBB06140263GA SBB06140265GA SBB06140266GA SBB06140270GA SBB06140290GA SBB06140293GA SBB06140279GA SBB06140280GA SBB06140287GA SBB06140346GA SBB06140348GA SBB06140349GA SBB06140353GA SBB06140354GA SBB06140356GA SBB06150393GA SBB06261196GA SBB06261199GA SBB06251122GA SBB06261164GA SBB06261168GA SBB06261174GA SBB06281253GA SBB06442791GA SBB06442801GA SBB06442808GA SBB06442814GA SBB06442822GA SBB06442841GA SBB06442842GA SBB06442847GA SBB06442849GA SBB06452929GA SBB06452937GA SBB06452947GA SBB06463042GA SBB06463048GA SBB06463052GA SBB06463055GA SBB06473062GA SBB06473063GA SBB06473066GA SBB06473079GA SBB06473092GA SBB06473095GA SBB06483125GA SBB06483129GA SBB06483135GA SCS06440389GA SCS06440393GA SCS06460454GA SCS06460459GA SCS06460461GA SBB07054052GA SBB07054093GA SBB07054094GA SBB07054096GA SBB07054116GA SBB07064134GA SBB07064139GA SBB07064172GA SBB07074249GA SBB07074255GA SBB07054016GA SBB07054022GA SBB07064127GA SBB07094279GA SBB07114328GA SBB07134417GA SBB07134422GA SBB07134423GA SBB07134426GA SBB07134429GA SBB07325311GA SBB07435898GA SBB07465993GA SBB07435891GA SBB07465996GA SBB07466021GA SBB07405607GA SBB08307124GA SBB08327193GA RST10129859GA RST10129860GA RST10129866GA RST10129867GA RST10129872GA SBB10129121GA SBB10129127GA SBB10129133GA SBB10129134GA SBB10129144GA RST10311218GA RST10311239GA RST10311240GA RST10311274GA RST10321454GA RST10422237GA RST10422254GA RST10422257GA RST10422258GA RST10422269GA SBB10410099GA SBB10410109GA SBB10410132GA SBB10410137GA SBB10430157GA SBB10430179GA SBB10430182GA SBB10430187GA SBB10430202GA SCS10365077GA SCS10365083GA SCS10455305GA SCS10465331GA SCS10465332GA SCS10465333GA M3HD4847F RT105100736GA RT105100749GA RT105120796GA RT105130919GA RT105140929GA RT105140936GA RT105140939GA RT105140941GA RT105140942GA RT105140943GA RT105140946GA RT105140964GA RT105140972GA RT105262035GA RT105262047GA RT105262066GA SBB08256964GA SBB08256969GA SBB08256984GA SBB08256986GA SBB08256996GA SBB08257013GA SBB08257031GA SBB08267040GA SBB08267041GA SBB08267048GA RT408258009GA RT408258011GA RT408268060GA RT408268069GA RT408268075GA RT408268078GA RT408298087GA RT408298088GA RT408298093GA RT408338102GA RT408338104GA RT408338109GA RT408338120GA RT408338134GA RT408338135GA RT408338136GA RT408338138GA RT408338139GA RT408358143GA RT408358144GA RT408358145GA RT408358147GA RT408358148GA RT408358156GA RT408358158GA RT408358162GA RT408358163GA RT408358164GA RT408358165GA RT408358166GA RT408358167GA RT408358169GA RT408358171GA RT408358172GA RT408358173GA RT408358176GA RT408358177GA RT408368188GA RT408368195GA RT408368196GA RT408368197GA RT408368201GA RT408368202GA RT408368203GA RT408368204GA RT408368206GA RT408368207GA RT408368208GA RT408378224GA RT408378236GA RT408378245GA RT408378257GA RT408378265GA RT408378268GA RT408378273GA RT408378276GA RT408388283GA RT408388284GA RT408388285GA RT408388286GA RT408388287GA RT408388288GA RT408388289GA RT408388290GA RT408388292GA RT408388293GA RT408388294GA RT408388295GA RT408388297GA RT408388298GA RT408388299GA RT408388300GA RT408388301GA RT408388302GA RT408388303GA RT408338127GA RT408388307GA RT408408314GA RT408408320GA RT408408323GA RT408408329GA RT408408333GA RT408408352GA RT408408355GA RT408408357GA RT408408358GA RT408408364GA RT408408366GA RT408408367GA RT409318900GA RT409318902GA RT409318909GA RT409398955GA RST10240507GA RST10240519GA RST10240521GA RST10240530GA RST10270797GA RST10270800GA RST10270801GA RST10280987GA RST10280992GA RST10280994GA RST10280995GA RST10280996GA RST10281004GA RST10281006GA RT410289447GA RT410289449GA RT410289452GA RT410289456GA RT410289458GA RT410289466GA RT410289473GA K2T14065G K2T14070G K2T14071G K2T14150G K2T14155G K2T14092G K2T14101G K2T14145G K2T14151G K2T14156G K2T14162G K2T14229G K2T14231G J2T14029G J2T14042G J2T14056G J2T14059G K2T14063G K2T14067G K2T14074G K2T14077G K2T14080G K2T14088G K2T14095G K2T14099G K2T14103G K2T14104G K2T14106G K2T14107G K2T14109G K2T14119G K2T14120G K2T14124G K2T14134G K2T14137G K2T14138G K2T14143G K2T14144G K2T14147G K2T14152G K2T14153G K2T14158G K2T14167G K2T14177G K2T14180G K2T14186G K2T14195G K2T14196G K2T14227G K2T14261G G2T13326G H2T13621G H2T13623G H2T13627G H2T13636G G2T13413G G2T13420G G2T13443G G2T13445G G2T13468G G2T13512G E2TW2857G H2TW3254G G2T13339G G2T13345G G2T13346G D2T12788G D2T12830G D2T12873G E2T12963G E2T13009G E2T13014G E2T13018G E2T13086G F2T13126G F2T13129G F2T13136G F2T13137G F2T13141G F2T13156G F2T13159G C2T12377G D2T12574G D2T12682G D2T12701G D2T12800G D2T12825G E2T12897G E2T12969G E2T12974G E2T12977G E2T12980G E2T13023G E2T13046G E2T13052G E2T13053G E2T13055G E2T13056G E2T13060G E2T13066G E2T13067G E2T13069G E2T13073G E2T13075G E2T13079G E2T13084G F2T13112G F2T13113G F2T13114G F2T13116G F2T13118G F2T13119G F2T13128G F2T13130G F2T13131G F2T13132G F2T13134G F2T13135G F2T13148G F2T13149G F2T13151G F2T13152G F2T13153G F2T13155G F2T13158G F2T13160G F2T13161G F2T13164G F2T13167G F2T13169G F2T13176G F2T13177G F2T13181G F2T13187G F2T13190G F2T13195G F2T13202G F2T13203G F2T13211G E2T13039G E2T13049G D0HB4427GR B3TW4319G B3TW4323G B3TW4340G B3TW4342G B3TW4350G B3TW4377G B3TW4380G B3TW4382G B3TW4386G B3TW4390G B3TW4392G B3TW4393G B3TW4398G B3TW4402G B3TW4496G B3TW4502G B3TW4505G A4TW5401G B4TW5519G B4TW5525G B4TW5578G H4T11734G H4T11750G H4T11752G H4T11754G H4T11756G H4T11792G H4T11798G H4T11799G M4T13110G M4T13114G M4T13115G M4T13116G M4T13118G M4T13120G M4T13122G M4T13123G M4T13125G M4T13126G M4T13152G M4T13154G M4T13160G M4T13165G M4T13167G M4T13180G M4T13183G M4T13194G M4T13227G M4T46110G SUSGNM47115 RT105453509GA RT105453544GA SCS06500651GA SCS07181135GA SBB07184673GA SBB07234864GA SBB07234865GA SBB07234870GA SBB07234875GA SBB07234876GA SBB07234878GA SBB07234880GA SBB07234882GA SBB07234885GA SBB07234887GA SBB07234890GA SBB07234891GA SBB07244937GA SBB07244942GA SBB07254960GA SBB07254962GA SBB07254974GA SBB07254975GA SBB07254980GA SBB07254983GA SBB07254985GA SBB07254994GA SBB07254995GA SBB07254998GA SBB07255001GA SCS07311413GA SCS07311421GA SBB07325331GA SBB06180432GA SBB07214829GA SBB07345435GA SBB07345439GA SBB07345451GA SBB07345457GA SBB07345461GA SBB07345462GA SBB07345471GA SBB07345481GA SBB07385490GA SBB07385498GA SBB07385501GA SBB07385505GA SBB07385506GA SBB07385507GA SBB07395521GA SBB07395530GA SBB07395532GA SBB07395539GA SBB07395543GA SBB07395549GA SBB07395550GA SBB07395570GA SBB07395575GA SBB07405591GA…
Recall started: Dec. 5, 2013
Device type: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Root cause (FDA): Pending
What the company told customers: GE Healthcare sent an Urgent Medical Device Correction letter dated December 5, 2013, to all affected customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Customers with questions were instructed to contact Technical Support at 1-800-558-7044. For questions regarding this recall call 262-513-4122.
Recall number: Z-0808-2014

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

Source: FDA · Medical device enforcement reports, recall numbers Z-0806-2014, Z-0807-2014, Z-0808-2014. The agency record governs; check it and the company before acting.

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