FDADecember 18, 2015device
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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns.
What to do
FDA enforcement status: Terminated
Brands named
neocoil
UPCs
000003440099000004040102000003340102000003440166000004040179000003340191000003440058000004040059000003340059000003440009000004040016000003340018
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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