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# iRhythm Gets Warning Letter on Heart Monitor
- URL: https://www.fdaweb.com/irhythm-gets-warning-letter-on-heart-monitor/
- Published: 2023-05-30T12:00:00.000Z
- Updated: 2026-09-14T18:34:53.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154573

iRhythm Technologies says it received a 5/25-dated Warning Letter that cites violations from an 8/22 agency inspection. “The Warning Letter alleges non-conformities to regulations for medical devices, including medical device reporting requirements, relating to the company’s Zio AT System and medical device quality system requirements,” iRhythm says in a note to investors.

The company says it has already responded to “certain items” cited in the letter after the company received the Form FDA-483 after the inspection concluded. The company intends to “continue to undertake certain corrections and corrective actions and provide regular updates to the FDA in response to the 483 observations,” it says.

iRhythm notes that the letter does not restrict the manufacturing, production or shipment of any products in the U.S. or require the withdrawal of any product from the U.S. marketplace. “At this time, the company believes that its receipt of this Warning Letter, without further adverse action initiated by the FDA, will not have a material impact to the company’s financial results,” it says.

The Zio AT System is described as a mobile cardiac telemetry monitor. The wireless patch can be worn for two weeks for detecting arrhythmias, the company says.