Recall Z-2225-2008 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare
GE 1.5T and 3.0T Signa HDX MR System Model Number(s): 2226300, 2377062-61, 2395001, 2395001-2, 5107849, and 5127452. This system is indicated for use as a diagnostic imaging device to produce axial sagittula, coronal and oblique images, spectroscopic images, and or spectra, dynamic images of the internal structure or organs of the entire body,
| Date | Sep 11, 2008 (initiated Mar 28, 2008) |
| Status | Terminated |
| Reason | Possible misdiagnosis or inappropriate treatment based on the image. Signal homogeneity may be affected when BRAVO applications are set with IR Prep off. The concern is that signal inhomogeneity can result in an erroneous diagnosis. |
| Root cause | Software change control |
| Action | Customer Letter and Operator Manual addendum were sent directly to customers in August 2008. When the software correction is issued, GE Field Engineer will visit each site to implement the correction. (Not conducted yet) |
| Quantity | 720 units (360 US / 360 OUS) estimate |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS,MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA,WI, and WV. Countries of Argentina Australia Austria Belgium Brazil Canada Chile China Czech Republic Denmark Finland Fran |
| 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 |