{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Waukesha", "state": "WI", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "66254", "recalling_firm": "GE Healthcare, LLC", "address_1": "3000 N Grandview Blvd", "address_2": "", "postal_code": "53188-1615", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "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.", "recall_number": "Z-0021-2014", "product_description": "GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended for general purpose diagnostic fluoroscopy and radiography studies.", "product_quantity": "2184 (1063 US. 1121 OUS)", "reason_for_recall": "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.", "recall_initiation_date": "20130816", "center_classification_date": "20131017", "termination_date": "20140530", "report_date": "20131023", "code_info": "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 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318473RCATH2X 00000501908WK8 318798HCATH2 00000454725WK3 402280P1 00000431831WK7 LIJ201178 00000503601WK7 MCTH006YX 00000506323WK5 0910062022 00000418480WK0 0647 00000428844WK5 0792 00000428196WK0 0814 00000437685WK1 0820 00000435118WK5 61993 00000421055WK5 6622LCDLX 00000518759WK6 MA1190VA01 00000316517WK2 0000000 00000333064WK4 417623FCV2 00000273112WK3 804862SR7A 00000336973WK3 MCTH050 00000297074WK7 MSIVASLC2 00000315101WK6 0053 00000330118WK1 060204 00000332783WK0 060205 00000319990WK8 BG4000RX01 00000387204WK1 75650ADVLCV 00000347541WK5 IR1026VA01 00000389587WK7 73959 00000519631WK6 215576LC1 00000459864WK5 RU1158VA03 No susp info 0002853879 No susp info 0002855112 No susp info 2022969CATH2 No susp info 214590CRS No susp info 215662LCLP2 No susp info 303629CL4 No susp info 316689MP No susp info 317818MDI140 No susp info 317818MDI145 No susp info 317818MDI155 No susp info 317818MDI175 No susp info 417837DX1 No susp info 440449EP No susp info 480474LC4 No susp info 507225CC101 No susp info 518387K12S35 No susp info 518387VASC1 No susp info 602258LC2 No susp info 671HVIGLCV No susp info 734426MIR2 No susp info 734426MIRGL No susp info 775770CATH3 No susp info 801566SPC No susp info 830334FCRF1 No susp info 913596GEMNET No susp info 936634WHLC No susp info AIM00902 No susp info CC68820 No susp info ECXV1407I No susp info MCTHWHS2 No susp info MEDIMGLCD No susp info NOPI00285 No susp info NOPI00286 No susp info RADNETRF1238 No susp info 2652ADVXLC No susp info 405949BLCA No susp info 7322AVTXLUC No susp info AH4300XR03 No susp info 6334 No susp info 9864 No susp info 13439 No susp info 39522 No susp info 40140 No susp info 45999 No susp info 060201 No susp info 75155 No susp info 80271 No susp info 99635 No susp info 0002686904 No susp info 0002774953 No susp info 0002830584 No susp info 0043-1 No susp info 3919-1 No susp info BG4549VA01 No susp info 23403ANGI1 No susp info 082406040027 No susp info 082406140006 No susp info 082416ATCINNOVA No susp info 3742513668 No susp info 33863SFX No susp info 07692ADVLC No susp info HR4008VA01 No susp info HR4032XR01 No susp info M2637311 No susp info HC3260XR03 No susp info 2543848ADVLC No susp info 2546301ADLCV No susp info 24516572980IN No susp info 083016592001782 No susp info 0835060001 No susp info IR1164XR01 No susp info IE6000VA01 No susp info A5360421 No susp info A5413834 No susp info BMALTA11 No susp info NXXXXX10 No susp info LY1006VA01 No susp info 33XVLCN544793 No susp info 4915LUC No susp info 64150LUC No susp info 6648LCV No susp info 8183MLCLHU No susp info 9926LCPLUS No susp info LCV+61055 No susp info 0920TESTEQUIP No susp info PK1183VA01 No susp info 21XR59740 No susp info 38223341XR No susp info 38239075LCV No susp info ADOMEDVA01 No susp info 787620IN4100 No susp info 809269LCA No susp info 809852INNOVA No susp info RO4165VA01 No susp info RU1041DM01 No susp info RU1195RX01 No susp info YU4060VA01 No susp info C99999164 No susp info DE539251 No susp info FA49RX02 No susp info FA57RX02 No susp info FA82RX02 No susp info NO003RX01 No susp info 0853060149 No susp info 34107VAS01 No susp info GE001VAS01 No susp info 10238VAS01 No susp info 388200-1XRAND No susp info 3882569347VAMET No susp info 388256938VASMET No susp info 388308XRAND No susp info 38839419VASMET" } ] }