Agency classClass IIOur severity:High FDA (Devices)·Z-0137-2022·Announced 2021-10-27

GE SIGNA MRI Systems Software Issue Causes Missing Image Slices

GE Healthcare's SIGNA Creator and SIGNA Explorer MRI systems may produce incomplete 3D images due to missing slices in software version DV29.1. Missing anatomical information could impact diagnostic accuracy.

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 a Class II medical device recall with risk-of-harm due to missing imaging slices that could affect diagnostic accuracy. No illnesses, injuries, or deaths are reported in the source material. The hazard is theoretical and risk-of-harm without confirmed clinical harm, placing it in the High (3) category per the rubric.

Plain-English summary

GE Healthcare is recalling SIGNA Creator and SIGNA Explorer nuclear magnetic resonance imaging (MRI) systems running software version DV29.1. Under certain conditions, the imaging software may fail to capture all image slices, resulting in missing anatomical data in 3D volume images.

The affected devices include 6 units distributed across multiple U.S. states and international locations. In the United States, distribution includes Arizona, California, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Texas, Virginia, Washington, and Puerto Rico. International distribution includes Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, the United Arab Emirates, and the United Kingdom.

The missing slices result in gaps of missing anatomy in the 3D reconstructed images. This incomplete imaging data could potentially impact the accuracy of clinical diagnosis and decision-making.

The recalled product

Product: SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Diagnostic Imaging / MRI
Hazard: missing-slices
imaging-defect
Affected units: 6

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

Distributed in 19 states:

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 →

Same manufacturer · GE Healthcare, LLC

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Same hazard · missing slices