The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1208-2013·Announced 2013-05-08

GE Healthcare Recalls 1.5T SIGNA HDe MR Systems for Image Flip Issue

GE Healthcare is recalling 822 GE 1.5T SIGNA HDe MR systems worldwide due to a software issue that may cause left-to-right image flips in specific reformatted views.

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 2/5 (Moderate).

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 hazard involves potential diagnostic errors due to image orientation flips, which is a significant quality issue but does not involve direct physical injury, death, or high-risk pathogens, fitting the Moderate category for software/labeling-related device defects without reported harm.

Plain-English summary

GE Healthcare, LLC is recalling 822 units of the GE 1.5T SIGNA HDe MR System, a diagnostic imaging device. The recall affects 154 units in the United States and 668 units outside the US. The systems were distributed worldwide, including nationwide in the US (excluding Rhode Island) and in numerous international locations.

The recall is due to a "Reformat Image Flip Issue" associated with GE MR Products. Specifically, axial and coronal reformatted images derived from sagittal 3D series (such as FSPGR-3D T1, BRAVO T1, or CUBE T1) containing more than 126 slices may display a left-to-right image flip. Additionally, the acquired sagittal images may be annotated with reversed left-right location annotations.

This issue may affect the accuracy of diagnostic imaging for patients who underwent specific 3D MRI sequences. Healthcare providers and facilities using these systems should verify if their equipment is affected by checking the serial numbers listed in the official recall notice and contacting GE Healthcare for remediation instructions.

The recalled product

Product
GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — MRI Scanner
Hazard

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 →

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