iRhythm recalls Zio AT ECG monitors with outdated labeling that may delay critical arrhythmia reporting to healthcare providers. Affected units include specific model parts sold with certain serial numbers.
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.
iRhythm is recalling Zio AT ambulatory ECG monitors that have outdated labeling. This could delay reporting of heart rhythm issues to healthcare providers, potentially affecting timely treatment.
The device's labeling shows that clinically important heart rhythm alerts are delayed until after patient registration completes. Additionally, the device has a limit on how many heart rhythm signals it can send before stopping, which could delay critical health information from reaching doctors.
People using Zio AT ECG monitors for heart rhythm monitoring are affected. Those with the specific model parts (ALB0031/07 or ALB0034/03) are most at risk.
Check for the Zio AT Clinical Reference Manual (part ALB0031) or Important Information Pamphlet (part ALB0034) with the model numbers ALB0031/07 or ALB0034/03. These parts were sold with specific serial numbers.
Look for the model numbers ALB0031/07 or ALB0034/03 on the device's reference manual or pamphlet.
The recall is due to outdated labeling that delays reporting of clinically significant heart rhythm issues to healthcare providers.
If you have the specific model parts (ALB0031/07 or ALB0034/03), you may experience delayed reporting of heart rhythm problems to your doctor.
Check your device's labeling for the model numbers ALB0031/07 or ALB0034/03. If you have these, contact iRhythm for guidance.
We’ve drafted a message you can send iRhythm to request your refund or repair — edit it as you like.
Subject: Recall Z-0183-2023 — iRhythm iRhythm Hello, I own a iRhythm that is covered by recall Z-0183-2023 from iRhythm. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
