Recall Z-2312-2016— NeoCoil, LLC

Name: FDA recall Z-2312-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-17

Class II · Terminated

Class II FDA medical device recall by NeoCoil, LLC, initiated 2016-06-17, terminated 2017-11-21. It names one FDA 510(k) clearance: K141832. 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.. Reason: There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil..

Recalling firm: NeoCoil, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-06-17
Terminated: 2017-11-21
Firm location: Pewaukee, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K141832 — 3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGENeocoil, LLC·cleared 2014-07-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.