FDA Medical Device Recalls (openFDA)
iRhythm Technologies, Inc.: Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system
- Recall number
- Z-0183-2023
- 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
- Status
- Open, Classified
- Initiated
- 2022-09-28
- Posted
- 2022-11-04
- Terminated
- not on file
- Reason
- 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
- 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 support@irhythmtech.com or your local sales representative.
- Quantity
- 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
- Lot, serial or model codes
- UDI-DI: 00869770000210; Model/Revision: ALB0031/07, ALB0034/03
- 510(k) numbers
- ["K163512"]
- PMA numbers
- not on file
- Product code
- DSI
- Firm FEI
- 3021769057
- Firm city
- Cypress
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28