GE Discovery MR750 MRI System May Produce Incomplete Diagnostic Images
GE Healthcare's Discovery MR750 3.0T MRI system may not capture all required image slices under certain conditions, resulting in gaps in diagnostic 3D images. Five devices are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is classified as FDA Class II with no reported illnesses or injuries. The hazard is a medical device defect affecting diagnostic imaging accuracy, making it a risk-of-harm product where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC has issued a recall for the Discovery MR750 3.0T nuclear magnetic resonance (MRI) imaging system running software version DV29.1. A total of 5 devices are affected by this recall.
Under certain conditions, the MRI system may fail to capture all image slices during the imaging process. This results in missing anatomical information in 3D volume images, which could affect the completeness of diagnostic studies.
The affected devices were distributed in the United States (Arizona, California, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Texas, Virginia, Washington, and Puerto Rico) and internationally (Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, United Arab Emirates, and United Kingdom).
The recalled product
- Product
- Discovery MR750 3.0T nuclear magnetic resonance imaging system
- Manufacturer
- GE Healthcare, LLC
- Hazard
- missing-image-slices
- diagnostic-imaging-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software version DV29.1
Distribution
Distributed in 18 states:
- AZ
- CA
- FL
- GA
- IL
- LA
- MA
- MD
- MN
- NC
- NH
- NJ
- NY
- OH
- OK
- TX
- VA
- WA
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