GE Healthcare…

Date

Feb. 26, 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

Product

GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station.

Reason

GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor and Dash Port 2 Docking Station: DASH: 1. Dash stops communicating on the Unity Network resulting in Loss of Monitoring at the CARESCAPE" CIC Pro Central Station*. 2. Dash displays distorted ECG waveforms in combination monitoring mode. 3. Dash incorrectly becomes Time Master on the Unity Network¿. 4.

Distribution pattern

Worldwide Distribution: USA (nationwide) including DC and PR; and Internationally to: ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOSNIA-HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CAMEROON, CANDA, CARIBBEAN, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DJIBOUTI, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GABON, GEORGIA, GERMANY, GHANA, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, IVORY COAST, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MACEDONIA, MALAYSIA, MALTA, MAURITIUS, MEXICO, MOLDOVIA, MOROCCO, NEPAL, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA MONTENEGRO, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SUDAN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, TAJIKISTAN, TANZANIA, THAILAND, TRINIDAD TOBAGO, TUNISIA, TURKEY, TURKMENISTAN, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM, YEMEN, and ZIMBABWE.

Quantity

178,711 (92,123 US, 86,588 OUS)

Codes and lots

Parent SN SBG06451608GA SBG06451606GA SBG06451607GA SBG06451638GA SBG06451605GA A4EH1211G A4EH1212G A4EH1251G A4EH1284G A4EH1286G A4EH1287G A4EH1288G A4EH1196G A4EH1197G A4EH1199G A4EH1203G A4EH1204G A4EH1281G A4EH1192G A4EH1193G A4EH1214G A4EH1227G A4EH1228G A4EH1216GR A4EH1219G A4EH1220GR A4EH1291G A4EH1191G A4EH1229G A4EH1230G A4EH1231G A4EH1240G A4EH1245GR A4EH1275G A4EH1264G A4EH1195G A4EH1246G A4EH1247G A4EH1267G A4EH1268GR A4EH1269G A4EH1271G A4EH1200G A4EH1249G A4EH1250G A4EH1254G A4EH1256G A4EH1257G A4EH1258G A4EH1201G A4EH1202G A4EH1222G A4EH1223G A4EH1205G A4EH1206G A4EH1224G A4EH1225G A4EH1226G A4EH3954GR A4EH1356G A4EH1359G A4EH1342G A4EH1343G A4EH1344G A4EH1345G A4EH1346G A4EH3471G A4EH3472G A4EH3475G A4EH3477G A4EH3478G A4EH3479G A4EH3483G A4EH3487G A4EH1334G A4EH1335G A4EH1336G A4EH1351G A4EH1353G A4EH1355G A4EH3461G A4EH3467G A4EH3468G A4EH1347G A4EH1339G A4EH1174G A4EH1175G A4EH1176G A4EH1180G A4EH1166G A4EH1189G A4EH1168G SBG06451639GA SBG06451640GA SBG06451643GA SBG06451645GA SBG06451646GA SBG06451647GA A4EH1172G A4EH1173G A4EH1295G A4EH1296G A4EH1297G A4EH1298G A4EH1299G A4EH1302G A4EH1310G A4EH1326G A4EH1327G A4EH1328G A4EH1304G A4EH1305G A4EH1306G A4EH1308G A4EH1318G SBG06451694GA SBG06451697GA SBG06451695GA SBG06451698GA SBG06451699GA SBG06451700GA SBG06451702GA E3DJ8567G B3DJ5517G B3DJ5145G B3DJ5502G K1DJ5583G D3DJ7826G SBG06451648GA SBG06451650GA SBG06451652GA SBG06451653GA SBG06451654GA SBG06451655GA SBG06451656GA SBG06451657GA SBG06451658GA SBG06451659GA SBG06451662GA SBG06451693GA SD011123114SA SD007387598GA SE511138483GA SD007397748GA DSH05221531GA K3EH7609G SE511138480GA SD008097705GA SD008097711GA AAB04469930GA SD007180035GA SD007241786GA SD007252045GA SD007252072GA SD010117127GA SD011225071SA H3EH4161G A4EH3811GR A4EH3813G A4EH3819G A4EH3820G A4EH3827G A4EH3828G A4EH3829G A4EH3830G A4EH3832G A4EH3833G A4EH3834GR A4EH3838G A4EH3839G A4EH3842G A4EH3846G A4EH3847G A4EH3849G A4EH3857G A4EH3860G A4EH3861G A4EH3862G A4EH3863G A4EH3864G A4EH3866G A4EH3869G A4EH3871G A4EH3872G A4EH3873G A4EH3874G A4EH3876G A4EH3877G A4EH3878G A4EH3879G A4EH3885G A4EH3888GR A4EH3895G A4EH3896GR A4EH3904G A4EH3905G A4EH3907G A4EH3908G A4EH3909G A4EH3910G A4EH3911G A4EH3912G A4EH3914G A4EH3915G A4EH3920G A4EH3921G A4EH3922G A4EH3923G A4EH3925G A4EH3926G A4EH3927G A4EH3928G A4EH3930GR A4EH3938G A4EH3939G A4EH3940G A4EH3944G A4EH3488G A4EH3489G A4EH3490G A4EH3491G A4EH3493G A4EH3495G A4EH3496G A4EH3498G A4EH3500G A4EH3501G A4EH3502G A4EH3503G A4EH3504G A4EH3505G A4EH3506G A4EH3507G A4EH3513GR A4EH3516G A4EH3517G A4EH3518G A4EH3519G A4EH3520G A4EH3521G A4EH3522G A4EH3526G A4EH3537G A4EH3538G A4EH3540G A4EH3541G A4EH3542G A4EH3544G A4EH3545G A4EH3546G A4EH3547G A4EH3548G A4EH3549G A4EH3550G A4EH3551G A4EH3552G A4EH3553G A4EH3554G A4EH3560G A4EH3562G A4EH3563G A4EH3572G A4EH3578G A4EH3585G A4EH3586G A4EH3588G A4EH3589G A4EH3590G A4EH3591G A4EH3596G A4EH3597GR A4EH3598G A4EH3599GR A4EH3600G A4EH3601G A4EH3602G A4EH3603G A4EH3604GR A4EH3605G A4EH3607G A4EH3608G A4EH3609G A4EH3610G A4EH3612G A4EH3613G A4EH3615G A4EH3616G A4EH3617G A4EH3618G A4EH3620G A4EH3621G A4EH3623G A4EH3624G A4EH3626G A4EH3627G A4EH3630G A4EH3634GR A4EH3643G A4EH3644G A4EH3645G A4EH3646G A4EH3647G A4EH3649G A4EH3650G A4EH3651G A4EH3652G A4EH3653G A4EH3665G A4EH3666G A4EH3668G A4EH3669G A4EH3670G A4EH3671G A4EH3672G A4EH3673G A4EH3674G A4EH3676GR A4EH3677G A4EH3678G A4EH3679G A4EH3681G A4EH3682G A4EH3689G A4EH3690G A4EH3691G A4EH3694G A4EH3696G A4EH3700G A4EH3704G A4EH3706G A4EH3707G A4EH3709G A4EH3710G A4EH3711G A4EH3712G A4EH3713G A4EH3714G A4EH3715G A4EH3716G A4EH3717G A4EH3721G A4EH3722GR A4EH3726G A4EH3733G A4EH3734G A4EH3735G A4EH3736G A4EH3737G A4EH3739G A4EH3740G A4EH3742G A4EH3743G A4EH3744G A4EH3745G A4EH3746G A4EH3749G A4EH3751G A4EH3756GR A4EH3758G A4EH3761G A4EH3762G A4EH3763G A4EH3764G A4EH3765G A4EH3766G A4EH3778G A4EH3779G A4EH3780G A4EH3781G A4EH3782G A4EH3783G A4EH3784G A4EH3785G A4EH3786G A4EH3787G A4EH3788G A4EH3789G A4EH3790G A4EH3793G A4EH3795G A4EH3796G A4EH3797G A4EH3798G A4EH3800G A4EH3802G A4EH3808G A4EH3809G A4EH4272G A4EH4275G A4EH4276G A4EH4277G A4EH4278GR A4EH4279GR A4EH4280G A4EH4281G A4EH4282G A4EH4283G A4EH4285G A4EH4286G A4EH4287G A4EH4288G A4EH4289G A4EH4292G A4EH4293GR A4EH4294G A4EH4302G A4EH4303G A4EH4304G A4EH4305G A4EH4306G A4EH4307G A4EH4309G A4EH4310G A4EH4311G A4EH4314G A4EH4317G A4EH4318G A4EH4322G A4EH4336G A4EH4337G A4EH4339G A4EH4340G A4EH4341G A4EH4342G A4EH4343G A4EH4344GR A4EH4351G A4EH4355G A4EH4356G A4EH4357G A4EH4358G A4EH4359G A4EH4360G A4EH4361G A4EH4362G A4EH4363G A4EH4366GR A4EH4369G A4EH4370G A4EH4378G A4EH4379G A4EH4381G A4EH4384G A4EH4385G A4EH4387G A4EH4388G A4EH4406G A4EH4407G A4EH4409G A4EH4410G A4EH4411G A4EH4413G A4EH4414G A4EH4415G A4EH3961G A4EH3962G A4EH3963G A4EH3971G A4EH3972G A4EH3973G A4EH3974G A4EH3975G A4EH3976G A4EH3977G A4EH3978G A4EH3979G A4EH3980G A4EH3981G A4EH3986G A4EH3987G A4EH3988G A4EH3989G A4EH3991G A4EH3992G A4EH4003G A4EH4010G A4EH4011GR A4EH4022G A4EH4024G A4EH4026G A4EH4035G A4EH4036G A4EH4038G A4EH4039G A4EH4040G A4EH4041G A4EH4042G A4EH4043G A4EH4044G A4EH4046G A4EH4047G A4EH4048G A4EH4062G A4EH4063G A4EH4064G A4EH4065G A4EH4067G A4EH4068G A4EH4069G A4EH4070G A4EH4072G A4EH4074G A4EH4075GR A4EH4077G A4EH4091GR A4EH4093G A4EH4094G A4EH4095G A4EH4096G A4EH4097G A4EH4099G A4EH4101G A4EH4102G A4EH4103G A4EH4104G A4EH4105G A4EH4107GR A4EH4108GR A4EH4111G A4EH4112G A4EH4113GR A4EH4114G A4EH4115G A4EH4116GR A4EH4117G A4EH4126G A4EH4127G A4EH4129G A4EH4132GR A4EH4133GR A4EH4149G A4EH4150G A4EH4152G A4EH4153G A4EH4154G A4EH4155G A4EH4156G A4EH4157GR A4EH4158G A4EH4160G A4EH4161G A4EH4162G A4EH4163GR A4EH4164G A4EH4166G A4EH4167G A4EH4168G A4EH4169G A4EH4170G A4EH4174G A4EH4181G A4EH4182G A4EH4184G A4EH4187G A4EH4188G A4EH4190G A4EH4191G A4EH4202G A4EH4205GR A4EH4207G A4EH4209G A4EH4210G A4EH4211G A4EH4212G A4EH4213G A4EH4214G A4EH4215G A4EH4216G A4EH4218G A4EH4219G A4EH4224GR A4EH4225G A4EH4227GR A4EH4228G A4EH4231G A4EH4233G A4EH4234GR A4EH4237G A4EH4240G A4EH4241G A4EH4242G A4EH4249G A4EH4252G A4EH4253G A4EH4255G A4EH4258G A4EH4261G A4EH4265GR A4EH4270G A4EH4271G AAB04180281GA AAB04180282GA AAB04180283GA AAB04180284GA AAB04180285GA AAB04180286GA AAB04180287GA AAB04180288GA AAB04180289GA AAB04190290GA AAB04190291GA AAB04190292GA AAB04190293GA AAB04190294GA AAB04190295GA AAB04190296GA AAB04190302GA AAB04190307GA AAB04190308GA AAB04190309GA AAB04190310GA AAB04190311GA AAB04190312GA AAB04190313GA AAB04190314GA AAB04190315GA AAB04190316GA AAB04190317GA AAB04190318GA AAB04190319GR AAB04190320GA AAB04190321GA AAB04190322GA AAB04190323GA AAB04190324GA AAB04190325GA AAB04190330GA AAB04190331GA AAB04190332GR AAB04190333GA AAB04190334GA AAB04190335GA AAB04190336GA AAB04190344GA AAB04190346GA AAB041903479GA AAB04190347GA AAB04190348GA AAB04190349GA AAB04190350GA AAB04190351GA AAB04190352GA AAB04190353GA AAB04190354GA AAB04190357GA AAB04190371GA AAB04190372GA AAB04190373GA AAB04190374GA AAB04190375GA AAB04190376GA AAB04190377GA AAB04190378GA AAB04190379GA AAB04190381GA AAB04190383GA AAB04190384GA AAB04190385GA AAB04190387GA AAB04190388GA AAB04190389GA AAB04190394GA AAB04190395GA AAB04190396GA AAB04190397GA AAB04190398GA AAB04190402GA AAB04190407GA AAB04190414GA AAB04190415GA AAB04190417GA AAB04190418GR AAB04190421GA AAB04190423GA AAB04190424GA AAB04190425GA AAB04190426GA AAB04190428GA AAB04190429GA AAB04190435GA AAB04190436GA AAB04190437GA AAB04190438GA AAB04190439GA AAB04190449GA AAB04190454GA A4EH4418G A4EH4420G A4EH4422G A4EH4426GR A4EH4428G A4EH4439G A4EH4443G A4EH4445G A4EH4449G A4EH4450G A4EH4452G A4EH4453G A4EH4454G A4EH4455G A4EH4456G A4EH4460G A4EH4462GR A4EH4465GR A4EH4477G A4EH4478G A4EH4479G A4EH4480G A4EH4481G A4EH4482G A4EH4484GR A4EH4485G A4EH4488G A4EH4489G A4EH4491G A4EH4492G A4EH4495G A4EH4496G A4EH4497G A4EH4499G A4EH4500G A4EH4501G A4EH4502G A4EH4503G A4EH4504G A4EH4505G A4EH4506G A4EH4508G A4EH4509G AAB03340003GP AAB03340006GP AAB03340008GP AAB03340009GP AAB03340010GP AAB03340011GP AAB03340014GP AAB03410017GP AAB03410018GA AAB03410022GP AAB03410026GA AAB03410027GA AAB04139260GA AAB04160031GA AAB04160035GA AAB04160036GA AAB04160037GA AAB04160038GA AAB04160042GA AAB04160043GA AAB04160044GA AAB04160045GA AAB04160046GA AAB04160047GA AAB04160048GR AAB04160049GA AAB04160053GR AAB04160054GR AAB04160078GA AAB04160079GA AAB04160080GA AAB04160081GA AAB04160082GA AAB04160085GR AAB04160086GA AAB04160087GA AAB04160088GA AAB04160089GA AAB04160090GA AAB04160091GA AAB04180103GA AAB04180104GA AAB04180117GA AAB04180118GA AAB04180119GA AAB04180120GA AAB04180121GA AAB04180122GA AAB04180123GA AAB04180124GA AAB04180126GA AAB04180127GA AAB04180128GA AAB04180129GA AAB04180130GA AAB04180137GA AAB04180138GA AAB04180139GA AAB04180140GA AAB04180141GA AAB04180142GA AAB04180156GA AAB04180165GA AAB04180166GA AAB04180167GA AAB04180168GA AAB04180169GA AAB04180184GR AAB04180186GA AAB04180187GA AAB04180188GA AAB04180189GA AAB04180190GA AAB04180191GA AAB04180192GA AAB04180193GA AAB04180194GA AAB04180195GA AAB04180201GR AAB04180202GR AAB04180203GA AAB04180204GA AAB04180205GR AAB04180207GA AAB04180211GA AAB04180212GA AAB04180213GA AAB04180218GR AAB04180219GA AAB04180247GA AAB04180248GA AAB04180249GR AAB04180250GA AAB04180251GR AAB04180252GA AAB04180253GR AAB04180254GA AAB04180255GA AAB04180256GR AAB04180257GA AAB04180258GA AAB04180259GA AAB04180260GA AAB04180261GR AAB04180262GA AAB04180263GA AAB04180264GA AAB04180265GA AAB04180266GA AAB04180267GA AAB04180268GA AAB04180269GA AAB04180270GR AAB04180271GA AAB04180272GA AAB04180273GA AAB04180278GR AAB04180280GA AAB04210832GA AAB04210833GA AAB04210834GA AAB04210835GA AAB04210836GA AAB04210837GA AAB04210838GA AAB04210839GA AAB04210840GA AAB04210841GA AAB04210843GA AAB04210845GA AAB04210847GA AAB04210849GA AAB04210850GA AAB04210851GA AAB04210852GA AAB04210853GA AAB04210854GA AAB04210855GA AAB04210856GR AAB04210859GA AAB04220860GA AAB04220862GA AAB04220863GA AAB04190467GA AAB04190468GA AAB04190472GA AAB04190473GA AAB04190474GA AAB04190475GA AAB04190476GA AAB04190477GA AAB04190478GA AAB04190479GA AAB04190480GA AAB04190481GA AAB04190482GA AAB04190483GA AAB04190484GA AAB04190485GA AAB04190486GA AAB04190487GA AAB04190488GA AAB04190489GR AAB04190495GA AAB04190496GA AAB04190497GA AAB04190498GA AAB04190500GA AAB04190501GR AAB04190504GR AAB04190505GA AAB04190506GA AAB04190507GA AAB04190508GA AAB04190509GA AAB04190510GA AAB04190511GA AAB04190512GR AAB04190515GA AAB04190516GA AAB04190517GA AAB04190520GA AAB04190521GA AAB04190523GA AAB04190524GA AAB04190527GA AAB04190528GR AAB04190529GR AAB04190530GA AAB04190531GA AAB04190536GA AAB04190538GA AAB04190539GA AAB04190541GA AAB04190542GA AAB04190543GA AAB04190544GA AAB04190545GA AAB04190546GA AAB04190547GA AAB04190549GA AAB04190550GA AAB04190551GA AAB04190552GA AAB04190553GA AAB04190554GA AAB04190555GA AAB04190558GA AAB04190559GA AAB04190560GA AAB04190562GA AAB04190566GA AAB04190568GA AAB04190570GA AAB04190573GA AAB04190578GA AAB04190579GA AAB04190580GA AAB04190581GA AAB04190582GA AAB04190583GA AAB04190584GR AAB04190585GA AAB04190586GA AAB04190593GA AAB04190594GA AAB04190595GA AAB04190596GA AAB04190599GR AAB04210614GA AAB04210615GA AAB04210616GA AAB04210617GA AAB04210619GA AAB04210620GA AAB04210621GA AAB04210622GA AAB04210623GA AAB04210624GA AAB04210625GA AAB04210626GA AAB04210627GA AAB04210628GA AAB04210629GA AAB04210630GA AAB04210631GA AAB04210632GA AAB04210633GA AAB04210634GA AAB04210635GA AAB04210636GA AAB04210640GA AAB04210641GA AAB04210642GA AAB04210643GA AAB04210644GA AAB04210645GA AAB04210646GA AAB04210647GA AAB04210648GR AAB04210649GA AAB04210656GA AAB04210678GA AAB04210680GA AAB04210681GA AAB04210682GA AAB04210685GA AAB04210687GA AAB04210689GA AAB04210690GA AAB04210702GA AAB04210703GA AAB04210704GA AAB04210705GA AAB04210706GA AAB04210707GA AAB04210708GA AAB04210709GA AAB04210710GA AAB04210716GA AAB04210717GA AAB04210718GA AAB04210719GA AAB04210720GA AAB04210721GA AAB04210722GA AAB04210728GR AAB04210734GA AAB04210736GA AAB04210737GA AAB04210738GA AAB04210739GA…

Recall started

Nov. 27, 2013

Device type

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Root cause (FDA)

Software design

What the company told customers

Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated November 27,2013. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (Contact Technical Support at 1-800-558-7044 or your local Service Representative).

Recall number

Z-0982-2014

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

Source: FDA · Medical device enforcement report, recall number Z-0982-2014. The agency record governs; check it and the company before acting.