# FDA recall Z-0183-2023

> **iRhythm Technologies, Inc.** · Class II · device recall initiated 2022-09-28.

## Product

Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034.  For Zio Ambulatory ECG monitoring system

## Reason for recall

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 for either type, any further transmissions for that type will cease. Risk of delayed reporting to health providers.

## Distribution

US: MD, NY, FL, TN, WA, AL, MA, AZ, CA, KS, HI, PA, NJ, TX, MN, VA, AR, OR, NC, CO, KY, MS, LA, MI, WI, WV, IN, ID, SC, CT, SD, IA, NV, OK, OH, IL, VT, NH, NE, NM, MO, ME, DC, RI, MT, DE, GA, ND

## Key facts

- **Recall number:** Z-0183-2023
- **Recalling firm:** iRhythm Technologies, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-09-28
- **Report date:** 2022-11-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cypress, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0183-2023

## Citation

> AI Analytics. FDA recall Z-0183-2023. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0183-2023. Source: US FDA. Licensed CC0.

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