Zio AT Ambulatory ECG Monitoring System Documentation Labeling Update
iRhythm Technologies is recalling clinical reference materials for the Zio AT cardiac monitoring system due to labeling deficiencies that may delay notification of arrhythmias to healthcare providers. Transmission limits could prevent critical cardiac event reporting.
- Product
- Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system
- Category
- Medical Device
- Distribution
- 48 states