FDAFDA · Food and drugs·Recall number Z-0021-2014
GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended for general purpose diagnostic fluoroscopy and radiography studies.
Published October 23, 2013 · Recall initiated: August 16, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
GE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardiovascular X-ray imaging systems.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare, LLC
- Distributor
- Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and except ND, SD and VT, and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA ARICA, CROATIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY,GREECE, GUADELOUPE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN,IRELAND, ITALY, JAMAICA, JAPAN,JORDAN, KAZKHSTAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, LIBYA ARAB JAMHIRIYA, LITHUANIA, MALAYSIA MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SLOVAKIA, SPAIN, SWEDEN, SYRIA, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UKRAINE, UNITED KINGDOM, and VENEZUELA.
- Lot
- Mfg Lot or Serial # System ID 00000026767YY4 201982LCA 00000068001YY7 901384LCA 00000033988YY7 914737LCA 00000034024YY0 954LCA1 00000031679YY4 708216LLCA 00000952037WK0 630856LCN 00000320794BU1 082406010002 00000346260BU3 DR-27820-CO 00000991021WK7 LB1160VA01 00000058879BU8 930047946 00000484712WK5 1453 00000529468WK1 915685LCA 00000528385WK8 082406040003 00000526149WK0 66324TC 00000497670WK0 M4017051 00000512202WK3 1616LCA 00000528587WK9 62134LCV+ 00000533252WK3 00001VAS01 00000548229WK4 506857LCA 00000088970BU9 0910063030 00000233847BU3 082406030001 00000238390BU9 083016598280384 00000245186BU2 RU1488RX20 00000249068BU8 34090VAS01 00000023887YY3 205599LCV 00000055095YY4 207283LC1 00000030139YY0 210428VCATH2 00000023954YY1 212604LC2 00000048123YY4 212604LCA2 00000048175YY4 214376VADV1 00000034312YY9 215576LC2 00000063851YY0 215662LCLP1 00000034351YY7 215955LCEP 00000034379448 216343LCA 00000026282YY4 216363LC 00000023914YY5 216384LCA 00000034355YY8 304256RCL1 00000055081YY4 304487LCA 00000048177YY0 305223LCV 00000023959YY0 305325LCA 00000063853YY6 307577HCL1 00000034352YY5 317818MDI111 00000055057YY4 317818MDI170 00000026283YY2 318462BCL 00000048183YY8 352333ANGIO 00000034327YY7 404991LCA 00000048150YY7 405271UC1 00000063859YY3 405359ELCV 00000023910YY3 407646CL1 00000034390YY5 409532GLCV 00000026316YY0 412578DLX 00000034341YY8 415540ADVLCLP 00000055053YY3 423493PSL 00000048145YY7 440585LCA 00000055092YY1 440835LCA 00000034383YY0 502587SP2 00000022054YY1 502933CL2 00000026276YY6 504380ADV1 00000048128YY3 540596LCV 00000034375YY6 561650LCA 00000030105YY1 601865ADY 00000030168YY9 615544LCA 00000034306YY1 615977SP 00000023934YY3 619340VA6 00000023871YY7 619347LC 00000030130YY9 619457SCL 00000026303YY8 619457SCL2 00000034347YY5 619739LC 00000055077YY2 661282CCLV 00000063864YY3 661326CATH1 00000030134YY1 704456LCV 00000034300YY4 707546ANGIO 00000030126YY7 717782LC1 00000034372YY3 717969LCC 00000030128YY3 718270LC 00000055052YY5 727521LCV 00000034376YY4 806358LCA 00000026272YY5 813462CATH 00000023936YY8 813586ADV1 00000055074YY9 828255MV5 00000030190443 903236LCA 00000034365YY7 904739CV2 00000048167YY1 904MHWCL 00000026290YY7 909387LCV 00000023920YY2 910343NHC1 00000026287YY3 910716BCL2 00000034391YY3 941629LCA 00000055059YY0 941798CATH1 00000048146YY5 972548CATH 00000048139YY0 CSI104 00000048156YY4 CSI106 00000026288YY1 DLPGMH1 00000022064YY0 M27036 00000039134YY1 704456LCV 0000048177YYO0 305223LCV 00000550095YY4 207283LC1 00000022059YY0 609757CCL3 00000026273YY3 813462CATH 00000030111YY9 801350LC2 00000030144YY0 908324CATH 00000022065YY7 1077 00000023879YY0 87373-1 00000023925YY1 082416170001 00000023960YY8 EG1005VA03 00000030181YY2 E4167601 00000048199YY4 M2147228 00000048102YY8 HC1251XR01 00000063868YY4 0835060003 00000063919YY5 IR1495VA01 00000063895YY7 A5111122 00000063910YY4 A5183634 00000048174YY7 A5214921 00000063921YY1 A5365407 00000063917YY9 A5367508 00000063920YY3 A5401513 00000063901YY3 C5120901 00000063877YY5 YX1122 00000063902YY1 YX1140 00000063894YY0 YX1185 00000063913YY8 YX1233 00000063912YY0 YX1314 00000063891YY6 LB1018VA01 00000026296YY4 LB1049VA02 00000030154YY9 LT4000VA02 00000034373YY1 14231LC 00000023958YY2 2235LCV 00000030151YY5 WRT0102 00000023942YY6 SA1000VA01 00000063880YY9 CE229631 00000063882YY5 FEB52037 00000063875YY9 YP629705 00000048103YY6 0853060152 00000048166YY3 0853060155 00000030115YY0 06008VAS02 00000023838YY6 215221CL1 00000063798YY3 303320CL1 00000063779YY3 303320CL2 00000063791YY8 312792RINOV2 00000022078YY0 314768SMLC 00000031479YY9 423493PCL1 00000023794YY1 516351LCA 00000048001YY2 516663LC3 00000031441YY9 603668CLC3 00000048085YY5 706354SLCA 00000031410YY4 708259NWLCA 00000048098YY8 765646CL1 00000048083YY0 770389LCA 00000063721YY5 909865LCLP 00000023830YY3 912633MCL1 00000063805YY6 BPEP 00000063736YY3 MCTHKGMN 00000022073YY1 215537LUA 00
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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