GE Healthcare Recalls Discovery MR750w Systems Due to Image Flip Defect
GE Healthcare is recalling 46 Discovery MR750w 3.0T MRI systems worldwide due to a potential image flip issue that may result in incorrect anatomical localization.
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: The recall is classified as FDA Class II and involves a diagnostic imaging defect that could lead to incorrect localization of anatomy and pathological findings, posing a risk of harm through misdiagnosis, though no specific injuries or illnesses are reported in the source text.
Plain-English summary
GE Healthcare, LLC is recalling 46 units of the Discovery MR750w 3.0T System (Part Number: 5352293) due to a potential issue with image flipping in the frequency encoding direction. This defect is associated with a specific workflow on the system and can cause images to be flipped in the superior/inferior, anterior/posterior, and right/left directions.
The image flip issue can result in the incorrect localization of anatomy and pathological findings, which may impact diagnostic accuracy. The affected units were distributed worldwide, including nationwide in the United States and in countries such as Australia, Canada, France, Germany, India, Japan, and the United Kingdom.
Healthcare facilities should contact GE Healthcare for instructions on how to address this issue. The recall is classified as Class II by the FDA, indicating that the defect may cause temporary or medically reversible health consequences.
The recalled product
- Product
- GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra,dynamic images of the stru
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — MRI System
- Hazard
- Affected units
- 46
Distribution
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