GE Healthcare Recalls SIGNA Pioneer MRI Systems Due to Date Errors
GE Healthcare is recalling 62 SIGNA Pioneer MRI systems because an installation issue may cause incorrect dates 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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall involves a documentation and metadata issue (incorrect dates on images) with no reported injuries or illnesses, fitting the criteria for cosmetic defects or documentation issues.
Plain-English summary
GE Healthcare, LLC is recalling 62 SIGNA Pioneer Nuclear Magnetic Resonance Imaging (MRI) systems. 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 because a potential installation workflow issue may cause the MRI system's date to be set incorrectly. Since the system's date and time settings are used to populate the DICOM header information on images, this error could result in inaccurate dates being recorded on the medical images.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this issue.
The recalled product
- Product
- SIGNA Pioneer 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
- Category
- Medical Device — MRI Scanner
- 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.
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