FEI 3007208829

Irhythm Technologies, Inc.

699 8th Street, San Francisco, CA, US

MDR events1,648All time

Recalls1All time

Registered products5

Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility

Registered product codes

5 product codes

Recent MDR events

1,648 on file

Recalls

1 on file

Open, ClassifiedNov 4, 2022
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.
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Compliance history

Matched by FEI 3007208829.

FDA inspections

2 on file

Official Action Indicated (OAI)Jul 31, 2024
Compliance: Devices · Citations posted
Voluntary Action Indicated (VAI)Jul 31, 2024
Postmarket Assurance: Devices · Citations posted

Inspection citations

3 on file

Top cited requirements

Compare to industry ↗

21 CFR 803.50(a)(2)Jul 31, 2024
Individual Report of Malfunction
21 CFR 820.30(g)Jul 31, 2024
Design Validation - Risk analysis not performed/inadequate
21 CFR 820.100(a)Jul 31, 2024
Lack of or inadequate procedures

Compliance actions

0 on file

No warning letters or injunctions on file for this FEI number.

Import refusals

0 on file

No import refusals on file for this FEI number.