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

FDA device recall Z-0183-2023 · posted 2022-11-04 · Open, Classified

Recall details

Recalling firm

iRhythm Technologies, Inc.

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.

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

DSI

Quantity affected

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

Date initiated

2022-09-28

Date posted

2022-11-04

Location

Cypress, CA

Related 510(k) clearances