Detector And Alarm, Arrhythmia
Cardiovascular · 21 CFR 870.1025
Recent MDR events
33,370 adverse event reports on file
- Reveal LINQJul 30, 2026MalfunctionMedtronic Singapore Operations3008973940-2026-05693
- Reveal LINQJul 30, 2026MalfunctionMedtronic Singapore Operations3008973940-2026-05719
- Reveal LINQJul 28, 2026MalfunctionMedtronic Europe Sarl9614453-2026-03018
- Reveal LINQJul 28, 2026InjuryMedtronic Europe Sarl9614453-2026-03020
- REVEAL LINQJul 22, 2026MalfunctionMedtronic Singapore Operations3008973940-2026-05488
- REVEAL LINQJul 22, 2026MalfunctionMedtronic Singapore Operations3008973940-2026-05492
- MEDTRONIC ILRJul 22, 2026MalfunctionMedtronic Neuromodulation2182207-2026-02014
- REVEAL LINQJul 22, 2026MalfunctionMedtronic Europe Sarl9614453-2026-02958
- INTELLIVUE MP50Jul 22, 2026InjuryPhilips Medizin Systeme Böblingen Gmbh9610816-2026-101485
- C6 MONITOR A13, VERIZONJul 22, 2026MalfunctionBraemar Manufacturing, Llc2133409-2026-00135
Event type breakdown
Recalls
82 recall events for this product code
- Spacelabs Healthcare, Inc.Open, ClassifiedMay 1, 2026
Brand Name: Spacelabs Ultraview SL Command Module
Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
Z-2052-2026 · View FDA record ↗ - Spacelabs Healthcare, Inc.Open, ClassifiedApr 7, 2026
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
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 measurement not automatically excluded, which may result in inaccurate readings, or the need of additional readings, which may lead to delayed care and/or fluid overload.
Z-1793-2026 · View FDA record ↗ - Philips North America LlcOpen, ClassifiedDec 2, 2025
IntelliVue MP2. Product Number: M8102A.
Potential issue where the IntelliVue monitors did not alarm.
Z-0849-2026 · View FDA record ↗ - Philips North America LlcOpen, ClassifiedDec 2, 2025
IntelliVue MP5. Product Number: M8105A.
Potential issue where the IntelliVue monitors did not alarm.
Z-0850-2026 · View FDA record ↗ - Philips North America LlcOpen, ClassifiedDec 2, 2025
IntelliVue MP20. Product Number: M8001A.
Potential issue where the IntelliVue monitors did not alarm.
Z-0851-2026 · View FDA record ↗ - Philips North America LlcOpen, ClassifiedDec 2, 2025
IntelliVue MP30. Product Number: M8002A.
Potential issue where the IntelliVue monitors did not alarm.
Z-0852-2026 · View FDA record ↗ - Philips North America LlcOpen, ClassifiedDec 2, 2025
IntelliVue MP40. Product Number: M8003A.
Potential issue where the IntelliVue monitors did not alarm.
Z-0853-2026 · View FDA record ↗ - Philips North America LlcOpen, ClassifiedDec 2, 2025
IntelliVue MP50. Product Number: M8004A.
Potential issue where the IntelliVue monitors did not alarm.
Z-0854-2026 · View FDA record ↗ - Philips North America LlcOpen, ClassifiedDec 2, 2025
IntelliVue MP60. Product Number: M8005A.
Potential issue where the IntelliVue monitors did not alarm.
Z-0855-2026 · View FDA record ↗ - Philips North America LlcOpen, ClassifiedDec 2, 2025
IntelliVue MP70. Product Number: M8007A.
Potential issue where the IntelliVue monitors did not alarm.
Z-0856-2026 · View FDA record ↗
Registered firms
368 firms currently registered for this product code
Gww
Gaertringen Baden-Wurttemberg, DE
Philips North America Llc
ANDOVER, MA, US
Philips North America Llc
Cambridge, MA, US
Zoll Manufacturing Corporation
Pittsburgh, PA, US
Ge Medical Systems Information Technologies
EL PASO, TX, US
Ge Medical Systems (china) Co., Ltd.
WUXI Jiangsu, CN
Ge Healthcare Finland Oy
HELSINKI Uusimaa, FI
Ge Medical Systems Information Technologies, Inc.
Wauwatosa, WI, US
Medtronic Europe Sarl
TOLOCHENAZ Vaud, CH
Shenzhen Mindray Bio-medical Electronics Co., Ltd.
Shenzhen Guangdong, CN
J&b Precision, Inc.
Cordova, TN, US
Philips Electronics Ltd
Mississauga Ontario, CA
Edan Diagnostics, Inc.
San Diego, CA, US
Amphenol Medical Technologies (dongguan) Co., Ltd.
Dongguan Guangdong, CN
Masimo Corporation
Irvine, CA, US
Philips North America Llc
Export, PA, US
Medicalgorithmics S.a.
WARSAW Mazowieckie, PL
B & G Mfg. Co.
HATFIELD, PA, US
Dre Med
Louisville, KY, US
510(k) clearances
398 clearances for this product code
- Boston Scientific Cardiac Diagnostic Technologies, Inc.Jan 23, 2026
K243349 · BodyGuardian Remote Monitoring System (BGRMS v3.0)
- Infobionic, Inc.Jul 29, 2025
K250356 · MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
- iRhythm Technologies, Inc.Oct 30, 2024
K240177 · Zio AT® device (A100A1001)
- Infobionic, Inc.Oct 6, 2023
K230265 · MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
- Smartcardia SAAug 30, 2023
K231276 · SmartCardia 7L Platform
- Medicalgorithmics S.A.Apr 9, 2020
K193104 · Unified Arrhythmia Diagnostic System PocketECG IV
- Preventice Technologies, Inc.Mar 26, 2020
K192732 · BodyGuardian Remote Monitoring System
- Medtronic, Inc.Sep 24, 2019
K190574 · Patient Assistant Model PA97000