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Detector And Alarm, Arrhythmia

FDA product code DSI · Class 2 · Cardiovascular

681
Registered devices
33,370
Adverse events
82
Recalls
398
510(k) clearances

Devices with this code

NA — Philips Medizin Systeme Böblingen GmbHNA — MEDTRONIC, INC.CARESCAPE B850 — GE Healthcare Finland OyAVIVO™ — MEDTRONIC, INC.SPACELABS HEALTHCARE — SPACELABS HEALTHCARE (WASHINGTON), INCSEEQ™ — MEDTRONIC, INC.BodyGuardian — PREVENTICE TECHNOLOGIES, INC.BodyGuardian — PREVENTICE TECHNOLOGIES, INC.Patient Monitor — Edan Instruments, Inc.Life Sensing Instruments, Inc. — LIFE SENSING INSTRUMENTS, INC.FUKUDA DENSHI — FUKUDA DENSHI CO.,LTD.RespArray — Edan Instruments, Inc.FUKUDA DENSHI — FUKUDA DENSHI CO.,LTD.FUKUDA DENSHI — FUKUDA DENSHI CO.,LTD.Trulink — SPACELABS HEALTHCARE (WASHINGTON), INCXHIBIT — SPACELABS HEALTHCARE (WASHINGTON), INCSEEQ™ — MEDTRONIC, INC.Life Sensing Instruments, Inc. — LIFE SENSING INSTRUMENTS, INC.Life Sensing Instruments, Inc. — LIFE SENSING INSTRUMENTS, INC.Reveal LINQ™ Insertion Tools — MEDTRONIC, INC.Trulink — SPACELABS HEALTHCARE (WASHINGTON), INCECG Electrodes — Philips Medical Systems HsgMatrix Mini ECG Module Kit — GLOBAL INSTRUMENTATION, LLCTrulink — SPACELABS HEALTHCARE (WASHINGTON), INC

Recent recalls

DateFirmReason
2026-03-26Spacelabs Healthcare, Inc.Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
2026-02-27Spacelabs Healthcare, Inc.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
2025-10-31Philips North America LlcPotential issue where the IntelliVue monitors did not alarm.
2025-10-31Philips North America LlcPotential issue where the IntelliVue monitors did not alarm.
2025-10-31Philips North America LlcPotential issue where the IntelliVue monitors did not alarm.
2025-10-31Philips North America LlcPotential issue where the IntelliVue monitors did not alarm.
2025-10-31Philips North America LlcPotential issue where the IntelliVue monitors did not alarm.
2025-10-31Philips North America LlcPotential issue where the IntelliVue monitors did not alarm.
2025-10-31Philips North America LlcPotential issue where the IntelliVue monitors did not alarm.
2025-10-31Philips North America LlcPotential issue where the IntelliVue monitors did not alarm.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.