NeoCoil, LLC recalls NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box. 3.…

Recall date

December 18, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1027-2016

FDA classification

Class II

Brand / firm

NeoCoil, LLC

Sold / distributed

US Nationwide Distribution

Why it was recalled

Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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