GE Healthcare Recalls MRI Systems Due to Potential Date Setting Error
GE Healthcare is recalling 62 MRI systems because a potential installation issue may cause incorrect dates to be recorded on medical images.
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 hazard involves a data integrity issue (incorrect dates on images) rather than a direct physical safety risk or reported illness, fitting the criteria for a moderate severity rating.
Plain-English summary
GE Healthcare, LLC is recalling 62 SIGNA Vibrant Nuclear Magnetic Resonance Imaging (MRI) systems, including 1.5T Signa HDx, 1.5T Signa HDxt, and Signa HDi models. The recall affects 30 units in the United States and 32 units in other countries, including Australia, China, France, Germany, India, Italy, Japan, the Netherlands, Oman, Spain, Sweden, Switzerland, Turkey, and the United Kingdom.
The recall was initiated because a potential installation workflow issue could result in the MRI system's date being set incorrectly. Since the system's date and time settings are used to populate the DICOM header information on images, this error could lead to inaccurate dates being recorded on the medical images.
The source text does not specify a corrective action for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this issue.
The recalled product
- Product
- SIGNA Vibrant Nuclear Magnetic Resonance Imaging System, 1.5T Signa HDx, 1.5T Signa HDxt, Signa HDi - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — MRI Systems
- Hazard
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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 4 products in this recall →Related recalls
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