Home › Device types › DSI
Detector And Alarm, Arrhythmia
FDA product code DSI · Class 2 · Cardiovascular
692
Registered devices
33,431
Adverse events
82
Recalls
398
510(k) clearances
Devices with this code
Q-Tel RMS — MORTARA INSTRUMENT, INC.Trulink — SPACELABS HEALTHCARE (WASHINGTON), INCTrulink — SPACELABS HEALTHCARE (WASHINGTON), INCAvalon Toco+ Transducer — Philips Medizin Systeme Böblingen GmbHTrulink — SPACELABS HEALTHCARE (WASHINGTON), INCNA — GE Medical Systems Information Technologies, Inc.PatientCare Link — PREVENTICE TECHNOLOGIES, INC.NIBP Cuffs — Philips Medical Systems HsgECG Electrodes — Philips Medical Systems HsgCARESCAPE B450 — GE Healthcare Finland OyPocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System — MEDICALGORITHMICS S AVitaLogik4500 — MENNEN MEDICAL LTD.Trulink — SPACELABS HEALTHCARE (WASHINGTON), INCQ-Tel RMS — MORTARA INSTRUMENT, INC.FUKUDA DENSHI — FUKUDA DENSHI CO.,LTD.BodyGuardian Kit — PREVENTICE TECHNOLOGIES, INC.Care Assist — Philips Medizin Systeme Böblingen GmbHTrulink — SPACELABS HEALTHCARE (WASHINGTON), INCTrulink — SPACELABS HEALTHCARE (WASHINGTON), INCTrulink — SPACELABS HEALTHCARE (WASHINGTON), INCPocketECG CRS - Medicalgorithmics Unified Cardiac Rehabilitation System — MEDICALGORITHMICS S ANA — GE Healthcare Finland OyVitalPatch™ 2.0 Single — Vital Connect, Inc.C6 Sensor — BRAEMAR MANUFACTURING, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-26 | Spacelabs Healthcare, Inc. | Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester). |
| 2026-02-27 | Spacelabs 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 |
| 2025-10-31 | Philips North America Llc | Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 | Philips North America Llc | Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 | Philips North America Llc | Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 | Philips North America Llc | Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 | Philips North America Llc | Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 | Philips North America Llc | Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 | Philips North America Llc | Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 | Philips North America Llc | Potential issue where the IntelliVue monitors did not alarm. |
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