Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil Recalled by NeoCoil, LLC Due to Potential for higher than specified surface temperatures. Use...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact NeoCoil, LLC directly.
Affected Products
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. 3.0T GEM Flex Coil 16-M Array, NC033000, GEHC part number 5430008-3. 3.0T GEM Flex Coil 16-S Array, NC034200, GEHC part number5430008-4. The 3.0T GEM Flex Coil (interface box and arrays) is used in conjunction with a 3.0T GE Magnetic Resonance Scanner
Quantity: 2121
Why Was This Recalled?
Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About NeoCoil, LLC
NeoCoil, LLC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report