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.

Recalled March 9, 2016 · FDA recall Z-1027-2016 · NeoCoil

Hazard

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

Units

2121

Sold at

US Nationwide Distribution

Description

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

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. 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

Manufacturer(s)

NeoCoil, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →