FDAFDA · Alimentos y medicamentos·N.º oficial Z-0982-2014
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station.
Publicado el 26 de febrero de 2014 · Inicio del retiro: 27 de noviembre de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- GE Healthcare, LLC
- Distribuidor
- 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.
- Lote
- 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 A4EH3734
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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