Facility

IRHYTHM TECHNOLOGIES, INC.

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

Key facts

1recalls · worst Class II

2inspections · worst OAI

—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)	3007208829
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	699 8th Street San Francisco, CA, US 94103
Registration status	Active · expires 2026
Parent company	iRhythm Technologies, Inc. (owner-operator 10026250)
Brand names	Zio ECG Utilization Service (ZEUS) System

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Computer, Diagnostic, Programmable
Product code DQK (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1425

Recalls & enforcement

Class IIOngoing2022-09-28
Ambulatory ECG monitoring system labeling update: 1) Clinically actionable arrhythmia notifications delayed until patient registration is complete; 2) Patches limited to 100 symptomatic and 500 asymptomatic wireless transmissions; once the maximum transmission limit is reached fo…

FDA inspections (2)

VAI2024-07-31
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2016-06-29
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.

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. “IRHYTHM TECHNOLOGIES, INC. (FEI 3007208829) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007208829-irhythm-technologies-inc/

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