Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. Kenex Suspension installed with Radiation shield and lamp with following model numbers: E03971AA;E03981AA;E30421AA;E30431AA;E30591CA;E30591HD;E30591HL;E30591EB;E30511P;E30591AB;E30591B;E30511Q;E30591C;E30591A;E30591RR;E30591CB;E30591E;E33591PA;E33591PC. Product Usage: Personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation.

Detalles del retiro

Fabricante

GE Healthcare, LLC

Distribuidor

Worldwide Distribution - US Nationwide, ALBANIA, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MACEDONIA, MALAYSIA, MALTA, MARTINIQUE, MAURITIUS, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED KINGDOM, VENEZUELA, VIETNAM, and YEMEN.

Lote

Mfg Lot or Serial # System ID 00000226588WK2 309655FC1 00000215577WK8 312878WCL 00000224993WK6 318473RCATH2X 00000244933WK8 401274MV2 00000286625WK9 503230CV3 00000199483WK9 619457SCL 00000273112WK3 804862SR7A 00000234084WK2 915563LUADV 00000063736YY3 MCTHKGMN 00000416503WK1 1222 00000299868WK0 215662C3 00000312304WK9 215770C1 00000367696WK2 215861LC 00000312714WK9 301891LC 00000321508WK4 313421LC 00000309562WK7 317818MDI120 00000438039WK0 317818MDI905 00000503165WK3 318462BCL 00000505246WK9 318473RCATH4 00000281715WK3 318494LC1 00000405780WK8 318494LC2 00000405779WK0 401729PCL 00000455944WK9 402280P1 00000492511WK1 407646CL1 00000314328WK6 407896CCCATH 00000378033WK5 480474LC3 00000314429WK2 607763CL1 00000469188WK7 610250SC 00000399463WK9 615778ECL1 00000431048WK8 615781SHCV1 00000466434WK8 617340LC 00000280718WK8 618242GSLC 00000323794WK8 619543UC5 00000409286WK2 636933JMLC 00000320222WK3 708383OPLC 00000506007WK4 801350LC1 00000508243WK3 801350LC2 00000309699WK7 815963LC 00000285416WK4 817548ALC 00000273308BU7 901384LCA 00000399610WK5 909824LC2 00000421718WK8 909824LC3 00000475337WK2 910343NHC1 00000373273WK2 941475CL 00000504090WK2 DLPGMH1 00000283982WK7 E16327 00000432874WK6 LIJ201178 00000484098WK9 M27036 00000336973WK3 MCTH050 FMI12209DUM168 NSCXR 00000387613WK3 215221CL3 00000423269WK0 215785SCA 00000500248WK0 813462ADV1 00000215082WK9 316268SFCL 00000249758WK4 713791SCL3X 00000470720WK4 305395B44 00000319310WK9 313745CATH2 00000414277WK4 415428OCCL2 00000459249WK9 507255CC101 00000409553WK5 602258LC1 00000450389WK2 619552VLC 00000293241WK6 808547QRM8A 00000496418WK5 912633MCL1 00000495821WK1 916734XR 00000289981WK3 M27037 00000497122WK2 215221CL1 00000143391WK1 0837YX0037 00000298765WK9 203872LUA 00000389718WK8 404422NR5 00000305860WK9 619421XSP 00000287562WK3 704255MMS2 00000315705WK4 714824LUA 00000227510WK5 714887LU 00000295578WK9 7186155N47 FMI12198DUM051 801566SPC 00000450489WK0 810664LUA 00000071592WK0 919748B10 00000286172WK2 214872NSP 00000251371WK1 301368LUB 00000313685WK0 401274MA1 00000340307WK8 573882VLUA 00000414828WK4 714827LUA FMI12209DUM169 805497RM4 00000481919WK9 313759LCV 00000325936BU3 317818MDI150 00000397838WK4 317818MDI909 00000487204WK0 619347LC 00000004534GP4 404501DLCA 00000113201BU8 0837YX0846 00000496940WK8 305325LCA 00000501336WK2 318388CLCA 00000495947WK4 504765LSP2 00000497921WK7 518761GLCA 00000507130WK3 606327ANGIO 00000493816WK3 619340VA6 00000502212WK4 706647LCA 00000497118WK0 717621LCA 00000497693WK2 718876LCA 00000492062WK5 804281ANGIO 00000506862WK2 864455GMSR9 00000537884WK9 901726M2LCA 00000421524WK0 213491AVTX 00000455854WK0 2135332W40 00000354299WK0 213726RM8 00000391955WK2 215546AFM 00000412426WK9 310673AFM 00000330894WK7 805SJAFM 00000369286WK0 908381AFM 00000548833BU3 AL4009VA02 00000548162BU7 AL4009VA01 00000488175BU1 DZ1006VA01 00000548332BU6 DZ1050VA01 00000008C20129 DZ1104VA01 00000567336BU3 DZ1292VA01 FMI12209DUMM23 DZ1057VA01 FMI12209DUMM24 DZ1087VA01 FMI12209DUMM25 DZ1130VA01 00000614763BU1 DZ1209VA01 00000000001332 DZ1351VA01 0000010C2M0363 DZ1399VA01 FMI12209DUMM26 DZ1415VA01 FMI12209DUMM39 DZ1483VA01 FMI12209DUMM57 DZ1192VA01 FMI12209DUMM58 DZ1503VA01 FMI12209DUMM93 DZ1061VA01 00000579051BU4 DZ1027VA02 0000000DUMMY12 DZ1060VA01 00000434301BU8 DZ1027VA01 FMI12209DUMM159 DZ1050VA02 UNK2335139-603 AO1001VA01 FMI12198DUM024 2652ADVXLC 00000309014WK9 612576ADVX 000000TLK-3881 51230ADVLCX 00000580866BU2 341INV21 00000566829BU8 2722INV31 00000467850BU4 378INV31 00000557464BU5 4127INV31 00000570106BU5 4959INV31 00000011826BU5 512806ADVN 00000368409WK9 6124ADVCFM 00000252139BU1 1322875LCV 00000513495WK2 17883ADVLC 00000289992BU0 49638ADVXPF 00000506777WK2 0910062022 00000415812BU7 0910162004A 00000472994BU3 0910162009 00000447936BU6 0910163008 00000330900BU2 0910165002 00000569799BU0 0910064010 00000490794BU5 0910162010 000

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States