iRhythm Technologies, Inc.

Warning LetterOpen

Mr. Quentin S. Blackford President and CEO iRhythm Technologies, Inc. 699 8th Street, Suite 600 San Francisco , CA 94103 United States quentin.blackford@irhythmtech.comFEI 3021769057Issued May 25, 2023Center for Devices and Radiological Health

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3021769057.

Violations12

Issue DateMay 25, 2023

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: iRhythm Technologies, Inc.
Location: Mr. Quentin S. Blackford President and CEO iRhythm Technologies, Inc. 699 8th Street, Suite 600 San Francisco , CA 94103 United States quentin.blackford@irhythmtech.com
FEI Number: 3021769057
Country: United States
Issue Date: May 25, 2023
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

iRhythm Technologies, Inc. was cited for manufacturing the Zio AT System, a cardiac monitoring device intended for diagnosing heart arrhythmias, in violation of FDA Quality System Regulation (QSR) requirements and for operating with unapproved device components. During an FDA inspection of the company's Cypress, California facility in July-August 2022, investigators identified multiple compliance failures documented on Form FDA 483, with the company submitting responses across eight months (September 2022 through March 2023) that the FDA found inadequate to address the noted violations. The warning specifically highlighted that the Zio AT System, including its ZEUS software component used for ECG capture and arrhythmia analysis, was being distributed without proper regulatory clearance, despite the company holding clearance only for the separate Zio QX ECG Monitoring device.

iRhythm Technologies, Inc. FDA Warning Letter, May 25, 2023