FDA-Device2022-11-16Class II
Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system
iRhythm Technologies, Inc.
Hazard
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.
Sold states
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
Affected count
1,443
Manufactured in
6550 Katella Ave, N/A, Cypress, CA, United States
Products
Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0183-2023Don't want to check this manually?
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