FDAJune 17, 2016device
3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation. To be use...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil.
What to do
FDA enforcement status: Terminated
Brands named
neocoil
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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