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U.S. Department of Health and Human Services

Class 2 Device Recall Innova

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  Class 2 Device Recall Innova see related information
Date Initiated by Firm December 22, 2009
Date Posted January 13, 2010
Recall Status1 Terminated 3 on November 13, 2015
Recall Number Z-0621-2010
Recall Event ID 53788
510(K)Number K061163  
Product Classification table for x-ray system - Product Code MQB
Product Omega IV and Omega V tables on GE Innova 2121-1Q/3131--1Q Biplane Cardiovascular Imaging System.
Code Information 206598UWBP 214590EP2121 215576INNOVA2 253627INNOVA5 3108252121A 4146492121 541743CL5 617636IN2121 713794LAB11 904202WCL1 936WH2121 FHORLEP4 FHORLEP5 0853060201 YV0363 YV0365 YV0369 IE1100VA03 05448VAS01 HSRINNOVA1 416480INNOVA2 
Recalling Firm/
Manufacturer		 GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
Manufacturer Reason
for Recall		 Potential table rotation of Omega IV and Omega V tables affecting Advantx-E and Innova 2000, 2100IQ, 3100, 3100IQ, 4100, 4100IQ, 2121IQ and 3131IQ cardiovascular X-ray imaging systems. Due to potential weakness of some table rotational brakes, an unintended table rotation may occur while the table is locked. This issue could lead to a patient fall if the unintended motion occurs during patient
FDA Determined
Cause 2		 Device Design
Action Consignees were sent on 12/22/09 a GE Healthcare " Urgent Medical Device Correction" letter dated 12/1/09. The letter was addressed to Hospital Administrators / Risk Mangers, Mangers of Radiology / Cardiology, Radiologists / Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.
Quantity in Commerce 21
Distribution Worldwide distribution: USA, SRI LANKA, ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, BELARUS, BELGIUM, BOLIVIA, BOSNIA & Herzegovina, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, GERMANY, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, and YUGOSLAVIA.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MQB and Original Applicant = GE MEDICAL SYSTEMS, LLC
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