The Recall Desk
ModerateFDA (Devices)·Z-1207-2013·Announced 2013-05-08

GE Healthcare Recalls MRI Systems Due to Image Flip Defect

GE Healthcare is recalling 4,338 MRI systems because axial and coronal images from certain sagittal 3D series may display a left-to-right flip.

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: The recall is classified as FDA Class II. The defect involves image orientation errors which are a significant quality issue but do not present an immediate risk of serious injury or death, fitting the criteria for a moderate severity recall without reported harm.

Plain-English summary

GE Healthcare, LLC is recalling 4,338 units of its Discovery MR750, Discovery 450, Optima 450W, Signa HDx, Signa HDxt, Signa HDi, and Signa Vibrant MRI systems. The recall is due to a Reformat Image Flip Issue where axial and coronal reformatted images from a sagittal 3D series of over 126 slices may display a left-to-right image flip. Additionally, acquired sagittal images may be annotated with reversed left-right location annotations.

The affected devices are indicated for use as diagnostic imaging devices. The recall covers units distributed worldwide, including the United States (nationwide, DC, and Puerto Rico), excluding Rhode Island and specific listed countries. The source text does not report any illnesses, injuries, or deaths associated with this defect.

Healthcare facilities should contact GE Healthcare to verify if their specific serial numbers are affected and to obtain corrective action. The source text does not provide specific consumer instructions beyond the recall notification.

The recalled product

Product
GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant. Indicated for use as a diagnostic imaging device.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — MRI Systems
Hazard
Affected units
4,338

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · image flip

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