The FDA has posted 21 enforcement recalls of arrhythmia detector and alarm devices since 2025, none of them Class I (most serious). Most recent report: May 13, 2026.
Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO mea…
Potential issue where the IntelliVue monitors did not alarm.
Potential issue where the IntelliVue monitors did not alarm.
Potential issue where the IntelliVue monitors did not alarm.
Potential issue where the IntelliVue monitors did not alarm.
Potential issue where the IntelliVue monitors did not alarm.
Potential issue where the IntelliVue monitors did not alarm.
Potential issue where the IntelliVue monitors did not alarm.
Potential issue where the IntelliVue monitors did not alarm.
Potential issue where the IntelliVue monitors did not alarm.
Potential issue where the IntelliVue monitors did not alarm.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Detector And Alarm, Arrhythmia”). Informational only — verify against the FDA before acting.