NeoCoil 3.0T GEM Flex Coil Recalled for Potential Burn Risk
NeoCoil, LLC is recalling 2,121 units of the 3.0T GEM Flex Coil system due to a potential for higher than specified surface temperatures that may result in patient warming or burns.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of burns, which aligns with the rubric criteria for Severe severity involving significant injury reports or high-risk device defects.
Plain-English summary
NeoCoil, LLC is recalling 2,121 units of the NeoCoil 3.0T GEM Flex Coil system. The recall is being conducted because the device has a potential for higher than specified surface temperatures. Use of the 3.0T GEM Flex system may result in patient warming or burns.
The affected product is the NeoCoil 3.0T GEM Flex Coil, which includes three sizes of coil arrays and one interface box. The system is used in conjunction with a 3.0T GE Magnetic Resonance Scanner. The recall covers units distributed nationwide in the United States.
The FDA has classified this recall as Class II. Consumers and healthcare facilities should stop using the affected devices and contact NeoCoil, LLC for further instructions on the recall.
The recalled product
- Product
- NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box. 3.0T GEM Flex, Interface 16ch Fixed, P -Connector, NC032204, GEHC part number 5430008-5. 3.0T GEM Flex Coil16-L Array, NC040200, GEHC part number 5430008-2.…
- Manufacturer
- NeoCoil, LLC
- Category
- Medical Device — MRI Coil
- Affected units
- 2,121
Distribution
Distributed nationwide across the United States.
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