The Recall Desk
ModerateFDA (Devices)·Z-0693-2019·Announced 2019-01-16

GE Healthcare Recalls MRI Systems Due to Possible Incorrect Software Version

GE Healthcare is recalling 3,849 MRI systems worldwide because they may have an incorrect software version loaded.

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, and the source text describes a potential software error without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.

Plain-English summary

GE Healthcare, LLC is recalling 3,849 units of various GE Magnetic Resonance Systems for general diagnostic use. The recall is being conducted because the systems may have a possible incorrect software version loaded.

The affected equipment is distributed worldwide, including across all 50 U.S. states, the District of Columbia, and numerous international countries. The recall covers a wide range of MRI models, including the Signa, OpenSpeed, EchoSpeed, HiSpeed, Brivo, Creator, Explorer, and HDXT series.

Consumers and healthcare facilities should contact GE Healthcare for further instructions regarding the software verification and correction process.

The recalled product

Product
Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Magnetic Resonance Imaging (MRI)
Hazard
Affected units
3,849

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Related recalls

Same manufacturer · GE Healthcare, LLC

See all →

Same hazard · software error

See all →