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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 5
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
Part of a larger recall action
This product is one of 10 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
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