Reported Nov 16, 2022 · Ongoing
Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio…
iRhythm Technologies, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: iRhythm Technologies, Inc. · 6550 Katella Ave · Cypress, CA · 90630-5102
Is this the product you have?
- Zio AT Clinical Reference Manual
- PartALB0031, and Zio AT Important Information Pamphlet
- PartALB0034. For Zio Ambulatory ECG monitoring system
- Lot codes and dates
- UDI-DI00869770000210
- Model/Revision
ALB0031/07ALB0034/03
- Amount recalled
- 1,443
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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