GE Healthcare MRI system button error causes incorrect diagnostic images
GE Healthcare's SIGNA MR355 and MR360 MRI systems are recalled due to a button UI issue that may cause diagnostic images to be flipped or incorrectly annotated. No patient harm has been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II FDA device recall involving a user-interface design issue that could result in diagnostic image errors. No patient illnesses or injuries have been reported, and the issue is operational in nature rather than an inherent device safety defect.
Plain-English summary
GE Healthcare is recalling the SIGNA MR355 and SIGNA MR360 Nuclear Magnetic Resonance Imaging Systems (MRI systems). The recall affects 242 units with worldwide distribution.
The issue involves the physical layout of the "Patient Orientation" button and the "Save RX" button on these systems. Operators may inadvertently click the "Patient Orientation" button when intending to click the "Save RX" button, changing the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan. This results in diagnostic images that are incorrectly annotated or flipped.
Incorrectly annotated or flipped diagnostic images may impact the accuracy of diagnostic interpretation. No patient illnesses or injuries have been reported related to this issue.
Facilities using these systems should be aware of this interface issue to prevent unintended patient orientation changes during image acquisition.
The recalled product
- Product
- SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Healthcare, LLC
- Hazard
- image-flip
- mis-annotation
Distribution
Distribution scope not specified by the agency.
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