The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0183-2023·Announced 2022-11-16

Zio AT Ambulatory ECG Monitoring System Documentation Labeling Update

iRhythm Technologies is recalling clinical reference materials for the Zio AT cardiac monitoring system due to labeling deficiencies that may delay notification of arrhythmias to healthcare providers. Transmission limits could prevent critical cardiac event reporting.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a high-risk medical device (ambulatory cardiac monitoring) where labeling deficiencies could delay critical arrhythmia notifications to healthcare providers. No illnesses or injuries have been reported, but the risk of delayed cardiac monitoring reporting qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

iRhythm Technologies, Inc. is recalling clinical reference manuals and patient information materials for its Zio AT Ambulatory ECG monitoring system. The affected products are the Zio AT Clinical Reference Manual (Part ALB0031) and Zio AT Important Information Pamphlet (Part ALB0034). A total of 1,443 units have been distributed nationwide.

The recall addresses two labeling deficiencies in the documentation. First, the materials do not clearly communicate that clinically actionable arrhythmia notifications will be delayed until patient registration is complete, which may prevent timely alerting of healthcare providers. Second, the documentation does not adequately inform users that wireless transmission patches are limited to 100 symptomatic and 500 asymptomatic transmissions; once either limit is reached, further transmissions of that type will cease. These transmission limits can result in data not being transmitted to clinicians.

The risk is delayed reporting of cardiac arrhythmias to health providers, which could impact patient care. Clinicians and patients who use or distribute the Zio AT system should review the updated documentation. iRhythm Technologies has issued corrected labeling materials. Healthcare providers and patients are advised to contact iRhythm Technologies for the updated information or to report any adverse events.

The recalled product

Product
Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system
Manufacturer
iRhythm Technologies, Inc.
Category
Medical Device — Cardiac Monitoring / Labeling
Hazard
Affected units
1,443

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • UDI-DI: 00869770000210
  • Model/Revision: ALB0031/07
  • ALB0034/03

Distribution

Distributed in 48 states:

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