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U.S. Department of Health and Human Services

Class 2 Device Recall Zio AT Clinical Reference Manual

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  Class 2 Device Recall Zio AT Clinical Reference Manual see related information
Date Initiated by Firm September 28, 2022
Date Posted November 04, 2022
Recall Status1 Open3, Classified
Recall Number Z-0183-2023
Recall Event ID 90954
510(K)Number K163512  
Product Classification Detector and alarm, arrhythmia - Product Code DSI
Product Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system
Code Information UDI-DI: 00869770000210; Model/Revision: ALB0031/07, ALB0034/03
Recalling Firm/
Manufacturer		 iRhythm Technologies, Inc.
6550 Katella Ave
Cypress CA 90630-5102
For Additional Information Contact
657-337-2468
Manufacturer 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.
FDA Determined
Cause 2		 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 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DSI and Original Applicant = IRHYTHM TECHNOLOGIES, INC.
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