Facility

SENSUS HEALTHCARE

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)	3008513398
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	851 Broken Sound Pkwy. NW#215 Boca Raton, FL, US 33487
Registration status	Active · expires 2026
Parent company	Sensus Healthcare (owner-operator 10033258)
Brand names	SRT-100 Vision

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (1)

System, Therapeutic, X-Ray
Product code JAD (opens in a new tab) · Class II · Radiology · 21 CFR 892.5900

Recalls & enforcement

Class IITerminated2023-02-10
When the user pauses the beam delivery, the dose timer is reset (to zero), and as a result may deliver an unexpected dose to the patient.

FDA inspections (3)

NAI2024-06-27
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act
VAI2022-08-05
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted
NAI2017-07-11
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 Sensus Healthcare

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. “SENSUS HEALTHCARE (FEI 3008513398) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008513398-sensus-healthcare/

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