GE 1.5T and 3.0T Signa HDx MR System The product is used as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the body.
Recall
- Recall Number
- Z-1890-2008
- Event Number
- 48073
- Firm
- GE Healthcare
- FEI Number
- 2126677
- Product Code
- LNH
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- December 14, 2007
- Posted
- September 17, 2008
- Terminated
- April 12, 2012
- Address
- 3000 N Grandview Blvd, Waukesha, WI, 53188-1615
Description
GE 1.5T and 3.0T Signa HDx MR System The product is used as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the body.
GE healthcare has become aware of an artifact which could affect the diagnostic capability associated with the 3.0T Propeller T2 Flair application of the 3.0T Signa HDx scanner.
Consignees were sent a "GE Healthcare Product Safety Notification" letter dated 9/14/07. The letter was addressed to Hospital Administrators, Managers of Radiology/Cardiology and Radiologists/Cardiologists. The letter described the safety issue, affected product, safety instructions, product correction and contact information. FMI 60745 and 60746 was communicated directly to the GE Healthcare service engineers who provide the modification at the customer site. For assistance, contact GE Healthcare at 1-262-544-3894.
AL, CA, CO,CT, AZ, FL, GA, LA, MS, MT, IA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NY, NV, OH, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PUERTO RICO. AUSTRALIA, CHINA, HONG KONG, INDIA, JAPAN, SOUTH KOREA, NEW ZEALAND, TAIWAN, SWITZERLAND, GERMANY, DENMARK, SPAIN, FRANCE, GREAT BRITAIN, IRELAND, IRAN, ITALY, KUWAIT, LEBANON, NETHERLANDS, NORWAY, RUSSIA, SAUDI ARABIA, TURKEY, SOUTH AFRICA, BRAZIL, CANADA, and MEXICO.
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