Electrocardiograph, Ambulatory, With Analysis Algorithm
Cardiovascular · 21 CFR 870.2800
Recent MDR events
23 adverse event reports on file
- SOFTWARE HSCRIBEJul 30, 2026MalfunctionBaxter Healthcare Corporation1316463-2026-00325
- CONTRACT EQ MM-HSCRIBE-DICOM MIDDLEWAREFeb 13, 2026MalfunctionMortara Instrument2183461-2026-00001
- RX-1 MINI RHYTHM EXPRESS REMOTE CARDIAC MONITORING SYSTEMOct 25, 2025MalfunctionVivaquant, Inc3011937459-2025-03527
- BODYGUARDIAN MINI - REMOTE CARDIAC MONITORAug 7, 2025InjuryBoston Scientific Cardiac Diagnostic Technologies, Inc.MW5174152
- PHILIPS EXTENDED HOLTER EPATCH FLEX ADAPTERApr 29, 2025InjuryPhilips North America LlcMW5169622
- REACT DXJan 28, 2025InjuryMedicomp, Inc.MW5165356
- PHILIPS HOLTER SOFTWAREApr 5, 2024MalfunctionPhilips Medical Systems1218950-2024-00242
- PHILIPS HOLTER SOFTWAREFeb 2, 2024MalfunctionPhilips Medical Systems1218950-2024-00076
- CONTEC TLC 5000 DYNAMIC ECG SYSTEMSJun 23, 2023MalfunctionContec Medical Systems Co., Ltd.MW5118833
- PHILIPS HOLTER SOFTWAREJun 21, 2022MalfunctionPhilips North America Llc1218950-2022-00504
Event type breakdown
Recalls
2 recall events for this product code
- Baxter Healthcare CorporationOpen, ClassifiedNov 7, 2024
Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
Z-0320-2025 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedNov 7, 2024
Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
Z-0323-2025 · View FDA record ↗
Registered firms
37 firms currently registered for this product code
Contec Medical Systems Co., Ltd
Qinhuangdao Hebei, CN
Welch Allyn De Mexico, S. De R.l. De C.v.
TIJUANA Baja California, MX
Global Instrumentation, Llc
E Syracuse, NY, US
Emsere, Inc.
Peachtree City, GA, US
Welch Allyn, Inc.
Skaneateles Falls, NY, US
Philips North America Llc
Export, PA, US
Cardiabase
Nancy Meurthe-et-Moselle, FR
Norav Medical Inc.
Delray Beach, FL, US
Philips North America Llc
ANDOVER, MA, US
Philips (china) Investment Co., Ltd. Philips Healthcare - Shanghai Cdc
SHANGHAI, CN
Icon Llc
Rochester, NY, US
Philips North America Llc
Cambridge, MA, US
Bittium Biosignals Ltd.
KUOPIO Pohjois-Savo, FI
Cardiocalm Srl
Montichiari Brescia, IT
Pt Giken Precision Indonesia
Batam Riau, ID
Norav Medical Ltd.
YOKNEAM Northern, IL
Labtech Kereskedelmi Es Mernoki Szolgaltato Kft
Debrecen Hajdu-Bihar, HU
Vivaquant, Inc
Arden Hills, MN, US
Porticos Asia Limited
Hong Kong, HK
Medisono, Llc
Doral, FL, US
Philips North America Llc
Murrysville, PA, US
Quipment Inc.
Kennesaw, GA, US
Neurotronics, Llc
Alachua, FL, US
510(k) clearances
32 clearances for this product code
- Philips Medizin Systeme Böblingen GmbHMar 21, 2025
K241890 · Philips Holter Analysis System
- Fourth Frontier Technologies Pvt, Ltd.Nov 8, 2024
K240794 · Frontier X Plus
- VivaQuant, Inc.Sep 2, 2020
K200833 · RX-1 Rhythm Express Remote Cardiac Monitoring System
- CardiocalmAug 26, 2020
K193177 · CER-S
- Bittium Biosignals , Ltd.Nov 8, 2018
K182030 · Faros Mobile
- Labtech Kft.Dec 5, 2014
K140847 · CARDIOSPY ECG HOLTER SYSTEMS
- Vales & Hills Biomedical Tech. , Ltd.Nov 26, 2013
K131897 · CV3000 HOLTER ANALYSIS SYSTEM
- Inovise Medical, Inc.Oct 11, 2013
K130660 · AUDICOR CPAM WITH SDB (SINGLE SENSOR)