The Recall Desk
SevereFDA (Devices)·Z-1027-2016·Announced 2016-03-09

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Hazard
Affected units
2,121

Distribution

Distributed nationwide across the United States.

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