GE Medical Systems Recalls SIGNA Pioneer MR Systems Due to Ferrous Material Risk
GE Medical Systems is recalling 16 SIGNA Pioneer MR systems because ferrous material in the Table Control Box could cause unexpected attraction to the magnetic field during servicing, posing a risk of serious injury to personnel.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of serious injury to service personnel due to magnetic attraction, but the source explicitly states that no events or injuries have been reported, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
GE Medical Systems, LLC is recalling 16 SIGNA Pioneer MR systems, a whole-body magnetic resonance scanner used for diagnostic imaging. The recall is due to the presence of ferrous material in the Table Control Box (TCB). This material could cause the TCB to be unexpectedly attracted to the MR system's high-strength magnetic field during servicing activities.
The hazard presents a potential risk of serious injury to service personnel who attempt to inappropriately remove the TCB from the magnetic field. The source text states that there have been no events reported as a result of this issue.
The affected units are distributed worldwide, including in the United States (specifically South Carolina and North Carolina) and in Australia, Canada, France, Germany, Japan, and Turkey. Specific serial numbers and system IDs for the 16 affected units are listed in the recall documentation.
The recalled product
- Product
- SIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal…
- Manufacturer
- GE Medical Systems, LLC
Distribution
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