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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare MRI systems with Confirmas CADstream

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 Class 2 Recall
GE Healthcare MRI systems with Confirmas CADstream
see related information
Date Posted January 11, 2010
Recall Status1 Terminated on August 03, 2012
Recall Number Z-0592-2010
Recall Event ID 53957
Premarket Notification
510(K) Numbers
K041476  K052293  K052978  K081028  K083147 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa HDxT 1.5T, Signa HDe, GE DISCOVERY MR450 and the Signa 3.0T MR750 MRI systems when used in conjunction with Confirma's CADstream (These systems contain the PURE software option.) Excite MR system is indicated for use as a diagnostic imaging device to produce images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body.
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Recalling Firm/
Manufacturer
GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
GE Healthcare has recently become aware that the use of Confirma, Inc.'s CADstream in conjunction with the GE Healthcare's PURE (Phased Array Uniformity Enhancement) software for dynamic MRI imaging (Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa HDxT 1.5T, Signa HDe, GE DISCOVERY MR450 and the Signa 3.0T MR750 MRI systems ) may require a modification to the study preference settings to p
FDA Determined
Cause 2
DESIGN: Software Design
Action GE Healthcare issues an "Important Product Information" letter dated October 23, 2009. The letter was addressed to Hospital Administrators, Managers of Radiology and Radiologists. The letter listed the Issue, Affected Product Details, Instructions, Product correction and Contact Information. For further information, contact GE Healthcare at 1-262-548-2731.
Quantity in Commerce 5460
Distribution Worldwide Distribution -- All States in the US including DC and Puerto Rico. OUS: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BELGIUM, BOLIVIA, BOSNIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, ISLAMIC IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KOREA REPUBLIC, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB, LITHUANIA, LUXEMBOURG, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB, UNITED KINGDOM, UZBEKISTAN, VENEZUELA and VIETNAM.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = GE MEDICAL SYSTEMS, LLC
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