GE Healthcare Recalls SIGNA Premier MRI Systems Due to Date Errors
GE Healthcare is recalling 62 SIGNA Premier MRI systems because a potential installation issue could 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 involves a data integrity issue (incorrect dates on images) rather than a direct physical safety hazard or reported injury, fitting the criteria for a moderate severity recall.
Plain-English summary
GE Healthcare, LLC is recalling 62 SIGNA Premier Nuclear Magnetic Resonance Imaging (MRI) systems. These devices are whole-body magnetic resonance scanners designed to support high-resolution imaging and short scan times. The recall involves 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 due to a potential installation workflow issue that could cause the MRI system's date to be set incorrectly. Because the system's date and time settings are used to populate the DICOM header information on images, this error could result in an inaccurate date being recorded on the medical images.
This recall is classified as Class II by the U.S. Food and Drug Administration. Healthcare facilities and users of these systems should contact GE Healthcare for further instructions on how to resolve the date-setting issue.
The recalled product
- Product
- SIGNA Premier Nuclear Magnetic Resonance Imaging System - 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
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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