Facility

SUMMIT INDUSTRIES, LLC

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

Key facts

1recalls · worst Class II

3inspections · worst VAI

—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)	1450503
Establishment type	Manufacture Medical Device
Location	7555 N. Caldwell Avenue Niles, IL, US 60714
Registration status	Active · expires 2026
Parent company	SUMMIT INDUSTRIES, LLC (owner-operator 1450503)
Brand names	DFMT System; FMT System

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (2)

Solid State X-Ray Imager (Flat Panel/Digital Imager)
Product code MQB (opens in a new tab) · Class II · Radiology · 21 CFR 892.1680
System, X-Ray, Stationary
Product code KPR (opens in a new tab) · Class II · Radiology · 21 CFR 892.1680

Recalls & enforcement

Class IITerminated2014-10-28
The welds on J700 tube stands may be insufficient resulting in tube stand breakage, damage to the X-Ray machine, and/or patient or healthcare provider injury.

FDA inspections (3)

VAI2025-03-20
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2022-09-30
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted
VAI2017-09-29
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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 SUMMIT INDUSTRIES, 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. “SUMMIT INDUSTRIES, LLC (FEI 1450503) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1450503-summit-industries-llc/

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