Facility

QUALITY ELECTRODYNAMICS

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

Key facts

2recalls · worst Class II

1inspections · worst NAI

—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)	3007350713
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	6655 Beta Drive Suite 100 Mayfield Village, OH, US 44143
Registration status	Active · expires 2026
Parent company	Quality Electrodynamics (owner-operator 10023379)
Brand names	16ch Foot/Ankle SPEEDER

Activity by year

Recalls (2)
Inspections (1)

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 IITerminated2019-08-20
Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
Class IITerminated2012-07-27
On July 27, 2012, it was reported to the firm that the Siemens 3T 15ch Knee Coil was not functional because the coil identification code for the device was incorrect.

FDA inspections (1)

NAI2016-09-16
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Quality Electrodynamics

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. “QUALITY ELECTRODYNAMICS (FEI 3007350713) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007350713-quality-electrodynamics/

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