GE 1.5T and 3.0T Signa HDx MR System Model Numbers: 5127452, 2377062-61, and 2395001-2. 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, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body.
Recall
- Recall Number
- Z-2210-2008
- Event Number
- 48683
- Firm
- GE Healthcare
- FEI Number
- 2126677
- Product Code
- LNH
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- October 1, 2007
- Posted
- September 16, 2008
- Terminated
- December 17, 2011
- Address
- 3000 N Grandview Blvd, Waukesha, WI, 53188-1615
Description
GE 1.5T and 3.0T Signa HDx MR System Model Numbers: 5127452, 2377062-61, and 2395001-2. 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, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body.
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.
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 both Inferior to Superior and Superior to Inferior directions and have no mismap between the functional and anatomical images.
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, China, Italy, Lebanon, Netherlands, Norway, Russian Federation, South Africa, Turkey, Iran, Kuwait, Taiwan, Switzerland, Germany, France, Great Britain, Ireland, Denmark, Spain, Saudi Arabia, and Macau.
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