Facility

OMEGA MEDICAL IMAGING, LLC

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

Key facts

4recalls · worst Class II

4inspections · 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)	1000222289
Establishment type	Manufacture Medical Device
Location	3400 St. Johns Parkway, Suite 1020 Sanford, FL, US 32771
Registration status	Active · expires 2026
Parent company	OMEGA MEDICAL IMAGING, LLC (owner-operator 9000656)
Brand names	Soteria Eview

Activity by year

Recalls (4)
Inspections (4)

Devices registered here (2)

System, X-Ray, Fluoroscopic, Image-Intensified
Product code JAA (opens in a new tab) · Class II · Radiology · 21 CFR 892.1650
Solid State Fluoroscopic X-Ray Imager
Product code QHY (opens in a new tab) · Class II · Radiology · 21 CFR 892.1650

Recalls & enforcement

Class IIOngoing2023-09-08
An actuator separated from the pivot mechanism on a lower monitor boom system column. The lower boom became detached at the point shown and was restrained by the installed safety cable.
Class IIOngoing2023-02-28
An actuator separated from the pivot mechanism on a lower monitor boom system column and became detached and was restrained by the installed safety cable at one location.
Class IITerminated2017-03-23
Elevating Monitor Suspension column dropping and will not rise back up.
Class IITerminated2016-06-21
Elevating Monitor Suspension separated from the lifting column bracket

FDA inspections (4)

NAI2025-09-29
No Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act; Postmarket Assurance: Devices
NAI2022-08-26
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted
VAI2018-11-28
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted
NAI2017-02-24
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · 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 OMEGA MEDICAL IMAGING, 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. “OMEGA MEDICAL IMAGING, LLC (FEI 1000222289) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000222289-omega-medical-imaging-llc/

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