GE Healthcare Recalls 3.0T MR750 MRI Scanners Due to Coil Overheating Risk
GE Medical Systems is recalling 356 Discovery 3.0T MR750 MRI scanners because a specific coil can overheat in Mode 2, posing a risk of serious patient thermal injury.
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 patient thermal injury from a medical device, but the source explicitly states that no injuries have been reported, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Medical Systems, LLC is recalling 356 units of the Discovery 3.0T MR750 MRI scanners, including 98 units in the United States and 258 units outside the US. The recall involves the 3.0T 6 Channel Flex Coil used with these surgical suite scanners. The affected systems are distributed worldwide, including in numerous US states and countries such as Canada, China, and the United Kingdom.
The recall is due to a potential safety issue where the coil can overheat when the device is used in Mode 2 setup. This overheating could lead to a serious patient thermal injury. GE Healthcare has stated that there have been no injuries reported as a result of this issue. An update to the recall in May 2016 expanded the scope to include Discovery 3.0T MR750 systems running specific application software versions (DV24 R01, DV25 R02, or DV25.1 M3).
Healthcare facilities using these specific MRI scanners should check their system serial numbers against the list provided in the official recall notice to determine if they are affected. If a system is included in the recall, the facility should contact GE Healthcare for instructions on corrective actions to prevent coil overheating.
The recalled product
- Product
- GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — MRI Scanner
Distribution
Part of a larger recall action
This product is one of 2 recalled by GE Medical Systems, 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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