Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT… recallZ-0183-2023 · iRhythm Technologies, Inc. · initiated Sep 28, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from iRhythm Technologies, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Device Design
What the company is doing
On 9/28/2022, Field Safety Notice Labeling Corrections were sent to customers who were informed of labeling changes and that the firm intends to enhance the process of notifying patients that they are approaching the maximum limit for either symptomatic or asymptomatic transmissions by auto shipping another Zio AT patch to the patient. Customers are asked to do the following: 1) Please review this letter and disseminate it to the appropriate system providers and any personnel at your facility. Please share this notification with all device users within your facility to ensure they are aware of this notice. 2) Complete and return the customer reply form. Further questions can be directed to customer care at (888) 693-2401 or [email protected] or your local sales representative.
Recall details
- Recall number
- Z-0183-2023
- Status
- Open, Classified
- Initiated by the company
- Sep 28, 2022
- Posted by the FDA
- Nov 4, 2022
- Recalling firm
- iRhythm Technologies, Inc.
- Quantity
- 1,443
- Product code
- DSI
- FDA submissions
- K163512
- 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
Product description
Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system
Code information (models, lots, serial numbers)
UDI-DI: 00869770000210; Model/Revision: ALB0031/07, ALB0034/03
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ZIO AT Patch A100A100XIrhythm Technologies, Inc. · Computer, Diagnostic, Programmable1 recall14 deaths629 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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