Drug recall
Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For…
FDA recall event 90954 · Class II · iRhythm Technologies, Inc.
Key facts
| Event ID | 90954 |
|---|---|
| Recall numbers | Z-0183-2023 |
| Recalling firm | iRhythm Technologies, Inc. |
| Product type | Devices |
| Products | Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Sep 28, 2022 |
| Report date | Nov 16, 2022 |
| City | Cypress |
| State | CA |
| Country | United States |
| FEI number | 3021769057 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: