Z-0183-2023Class II

Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034...

Name: Z-0183-2023 Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034...
Creator: iRhythm Technologies, Inc.
Published: 2022-09-28
License: https://open.fda.gov/license/

iRhythm Technologies, Inc. / initiated 2022-09-28 / Open, Classified / root cause: design

FDA source

iRhythm Technologies, Inc. began a recall of Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system on 2022-09-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0183-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-28
Posted: 2022-11-04
Recalling firm: iRhythm Technologies, Inc.
Product: Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system
Product code: DSI Detector And Alarm, Arrhythmia
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 1,443
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 codes and lots: UDI-DI: 00869770000210; Model/Revision: ALB0031/07, ALB0034/03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0183-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0183-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-16	2022-11-04

Product code DSI

K163512Class IIZio AT ECG Monitoring SystemiRhythm Technologies, Inc. / cleared 2017-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)