GE Healthcare Recalls SIGNA Creator and Explorer MRI Devices
GE Healthcare is recalling SIGNA Creator and SIGNA Explorer MRI scanners due to an incorrect RF Power Monitor Function that could cause higher than expected thermal dose and localized heating to patients.
What this means for you
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-harm product (thermal dose/heating) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
GE Healthcare, LLC is conducting a recall of SIGNA Creator and SIGNA Explorer diagnostic imaging devices. The recall involves an incorrect RF Power Monitor Function in these MRI scanners.
The defect could result in a higher than expected thermal dose to the patient and higher than expected localized heating. According to the source text, there have been no failures of this type reported, and no injuries have been reported as a result of this issue.
The recall affects 383 units distributed in the United States and various countries outside the US. Consumers and healthcare facilities should contact GE Healthcare for instructions on how to address this issue.
The recalled product
- Product
- GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — MRI Scanner
- Hazard
Distribution
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