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.
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, 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
- Hazard
- Affected units
- 3,849
Distribution
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