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Terminated

GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 53085735308573-2. GE Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T. The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. IT is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions 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. Depending on the region of interest being imaged, contrast agents may be used

FDA Recall Z-2266-2013 · Posted 2013-09-23

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeLNH
Date Initiated2013-04-09
Date Terminated2014-05-05
Product Quantity1,246 (521 US and 725 OUS)

Reason for Recall

GE Healthcare has recently become aware of a potential safety issue due to non-unique series identifiers embedded in image headers of certain GE MR Products. For ClariView and Screen Save from GVTK (Gems Visualization ToolKit) Viewer, the MR Product can generate image headers with non-unique series identifiers, which when exported to some PACS systems, results in the series being associated wit

Firm Action

Customers were sent two GE Healthcare "Urgent Medical Device Correction" letters one dated April 9, 2013, and the other May 22, 2013, each addressing one of the 2 groups of MR Products involved in the recall. The letters were addressed to Hospital Administrators / Risk managers, Radiology Department Mangers and Radiologists. The letters described the Safety Issue and provided Safety Instructions, Affected Product Details, Product Correction and Contact Information. GE Healthcare will correct all affected systems by providing a software update at no cost to you. A GE Healthcare service representative will contact you to arrange for this correction. Contact your local service representative if you have any questions concerning this notification. For further questions please call (262) 513-4122.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - All states in continental USA including DC except AK, AZ, RI and WY. and the countries of : AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEANON, MARINIQUE, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE,SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, LUXEMBOURG, PORTUGAL, VIETNAM and URUGUAY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K1216761.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANTGe Medical Systems, LLC · 2012-09-20K113490OPTIMA MR450WGe Medical Systems, LLC · 2012-01-13K103327DISCOVERY MR750W 3.0TGe Healthcare Japan Corporation · 2011-09-30K083147DISCOVERY MR450Ge Medical Systems, LLC · 2008-11-04K081028SIGNA 3.0T MR750 SYSTEMGe Medical Systems, LLC · 2008-04-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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