Recall Z-2211-2008 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare
GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System. Model Numbers 5107849, 5107849-2, M3000PT, and M3000PW . Indicated for use 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 entire body, including, but not limited to, head, neck, TMJ, sp
| Date | Sep 16, 2008 (initiated Oct 1, 2007) |
| Status | Terminated |
| Reason | A software issue that may result in misregistration of functional and anatomical images associated with the 3.0T BrainwaveRT fMRI Application on the 3.0T Signa HDx scanner. |
| Root cause | Software design |
| Action | A "GE Product Safety Notification" Customer letter addressed to Hospital Administrators, Managers of Radiology/Cardiology and Radiologists/Cardiologists dated September 14, 2007 was was sent to consignees. The letter described the safety issue, affected product, safety instructions, product correction and contact information. The letter instructed customers to scan only from the Superior to Inferior direction, when using BrainwaveRT with 2D T1 weighted scan. A GE Field Engineer site visit was also conducted to implement the correction (FMI No, 60745 & 60746), which enables users to scan in b |
| Quantity | 211 |
| Distribution | Worldwide Distribution --- USA including states of AL, AZ, CA, CO , CT, FL, GA ,IA , IL, IN , KY, LA, MA , MD, MI, MN, MO, MS, MT, NC, NE , NJ, NY , OH, OR, PA, PR,SD, TN, TX, UT, VA, WA, WI , and WV, the countries of Canada, Mexico, Brazil, New Zealand, Japan, Hong Kong, India, Korea, Australia, Ch |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041476 | GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM Ge Medical Systems, LLC, Jun 17, 2004 |