Discovery MR750w 3.0T MRI: Missing Image Slices in 3D Volume
GE Healthcare recalls the Discovery MR750w 3.0T MRI system. Under certain software conditions, image slices may be missing, creating gaps in 3D diagnostic images.
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 an FDA Class II medical device recall with no reported illnesses or injuries. The software condition creates a potential risk to diagnostic accuracy through missing image slices. Per the severity rubric, a risk-of-harm product without reported injury scores 3 (High).
Plain-English summary
The Discovery MR750w 3.0T is a nuclear magnetic resonance imaging (MRI) system manufactured by GE Healthcare, LLC. Thirteen devices have been distributed throughout the United States and in multiple international locations, including Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, the United Arab Emirates, and the United Kingdom.
Under certain conditions, the imaging software may fail to capture all required image slices during 3D volume reconstruction. This can result in missing anatomical information in the final diagnostic images. The FDA classified this as a Class II recall.
Affected healthcare facilities should contact GE Healthcare for information about software updates or other remedial actions. No illnesses or injuries have been reported. Patients who have undergone imaging should consult with their healthcare provider if they have concerns about the completeness of their diagnostic images.
The recalled product
- Product
- Discovery MR750w 3.0T nuclear magnetic resonance imaging system
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 13
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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