Reported Aug 10, 2016 · Terminated

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

NeoCoil, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: NeoCoil, LLC · N27W23910 Paul Rd Ste A · Pewaukee, WI · 53072-6204

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.

Lot codes and dates: "Neocoil serial Number"
046-4-0012
046-4-0013
046-4-0014
046-4-0015
046-4-0016
046-4-0017
046-4-0018
046-4-0019
046-4-0020
046-4-0021
046-4-0022
046-4-0023
046-4-0024
046-4-0025
046-4-0026
046-4-0027
046-4-0028
046-4-0029
046-4-0030
046-4-0031
046-4-0032
046-4-0033
046-4-0034
046-4-0035
046-4-0036
046-4-0037
046-4-0038
046-4-0039
046-4-0040
046-4-0041
046-4-0042
046-4-0043
046-4-0044
046-4-0045
046-4-0046
046-4-0047
046-4-0048
046-4-0049
046-4-0050
Amount recalled: 39 (11 US, 28 OUS)

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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