Facility

NEOCOIL, LLC

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3006369484
Establishment type	Manufacture Medical Device
Location	N27 W23910A PAUL RD. Pewaukee, WI, US 53072
Registration status	Active · expires 2026
Parent company	NeoCoil, LLC (owner-operator 9099325)
Brand names	NEOCOIL 3T 32-Channel Torso Coil

Activity by year

Recalls (2)

Devices registered here (1)

Coil, Magnetic Resonance, Specialty
Product code MOS (opens in a new tab) · Class II · Radiology · 21 CFR 892.1000

Recalls & enforcement

Class IITerminated2016-06-17
There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large Coil.
Class IITerminated2015-12-18
Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns.

All facilities operated by NeoCoil, LLC

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “NEOCOIL, LLC (FEI 3006369484) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006369484-neocoil-llc/

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