Facility

FIRST SOURCE INC.

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

Key facts

1recalls · worst Class II

5inspections · 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)	3004063527
Establishment type	Manufacture Medical Device
Location	3495 Winton Pl Bldg E Ste 1 Rochester, NY, US 14623
Registration status	Active · expires 2026
Parent company	First Source Inc (owner-operator 9056482)
Brand names	iQ Elevation; iQ Panorama

Activity by year

Recalls (1)
Inspections (5)

Devices registered here (1)

Cradle, Patient, Radiologic
Product code KXH (opens in a new tab) · Class I · Radiology · 21 CFR 892.1830

Recalls & enforcement

Class IIOngoing2024-05-09
Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.

FDA inspections (5)

NAI2026-06-24
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted
VAI2023-09-19
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted
VAI2021-07-20
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2018-05-25
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted
VAI2016-06-10
Voluntary Action Indicated · Compliance: 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 First Source Inc

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. “FIRST SOURCE INC. (FEI 3004063527) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004063527-first-source-inc/

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