Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system
FDA Recall Z-0183-2023 · Posted 2022-11-04
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Recalling FirmiRhythm Technologies, Inc.
Recall StatusOpen, Classified
Product CodeDSI
Date Initiated2022-09-28
Product Quantity1,443
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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