NeoCoil, LLC recalls 3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T

Recalled August 10, 2016 · FDA recall Z-2312-2016 · NeoCoil

Hazard

There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil. · FDA Class II

Units

39 (11 US, 28 OUS)

Sold at

Worldwide Distribution - US and Internationally to Georgia, Germany, Korea, Netherlands, Pakistan, Spain, Japan, and the United Kingdom.

Description

There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil.

Product

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 used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.

Manufacturer(s)

NeoCoil, LLC

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