GE Healthcare 3.0T MRI Flex Coil Recalled for Overheating Risk
GE Medical Systems is recalling 90 MRI coils because they may overheat in Mode 2, posing a risk of thermal injury to patients.
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 is classified as FDA Class II and involves a risk of serious thermal injury, but no injuries have been reported, fitting the criteria for a High severity score.
Plain-English summary
GE Medical Systems, LLC is recalling 90 units of the GE Healthcare 3.0T 6 Channel Phased Array Flex Coil (Model M0050SS). The recall involves 54 units in the United States and 36 units outside the US. The device is an accessory used with 3.0T MRI scanners to produce 2D and 3D images.
The recall was initiated because the coil can overheat when used in Mode 2 setup. This overheating could lead to a serious patient thermal injury. The FDA has classified this as a Class II recall. There have been no injuries reported as a result of this issue.
The affected units were distributed worldwide, including in the United States, Canada, and numerous other countries. Users should stop using the affected coils in Mode 2 and contact GE Medical Systems for further instructions on the recall.
The recalled product
- Product
- GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Usage The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0T MRI scanner, as an accessory to produce 2D and 3D images.
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — MRI Coil
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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