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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova

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 Class 2 Device Recall GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innovasee related information
Date Initiated by FirmAugust 16, 2013
Date PostedOctober 17, 2013
Recall Status1 Terminated 3 on May 30, 2014
Recall NumberZ-0021-2014
Recall Event ID 66254
510(K)NumberK022322 K023178 K945375 K960575 K974367 K993037 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductGE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended for general purpose diagnostic fluoroscopy and radiography studies.
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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 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Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer 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.
FDA Determined
Cause 2
Process control
ActionConsignees were sent on 8/12/2013 a GE Healthcare "Urgent Medical device Correction" letter dated August 12, 2013. The letter was addressed to Hospital Administrators / Risk Mangers, Mangers of Radiology /Cardiology /Surgery Department and Radiologists /Cardiologists /Surgeons. The letter described the Safety Issue, safety Instructions, Affected Product details, Product Correction and Contact Information (US 800-437-1171, Japan 0120 055 919).
Quantity in Commerce2184 (1063 US. 1121 OUS)
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OWB
510(K)s with Product Code = OWB
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