Recall Z-1890-2008 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare
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.
| Date | Sep 17, 2008 (initiated Dec 14, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 122 |
| Distribution | 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, IREL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052293 | GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM Ge Medical Systems, LLC, Sep 21, 2005 |