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Holter Software Philips Holter Software (REF 860292)Recalls & reported problems

Philips Medical Systems Hsg · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838000469), received between Jun 21, 2022 and Jun 21, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Date/Time-Related Software Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Date/Time-Related Software Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 21, 2022Date/Time-Related Software Problem; Date/Time-Related Software Problem

    CUSTOMER REPORTED SOME OF THEIR STUDIES ARE NOT BEING CORRECTLY FLAGGED AS READ EVEN THOUGH THE DOCTOR IS READING THEM. FOR ONE STUDY, WHEN SEARCHING FOR A PATIENT STUDY TAKEN ON ONE DATE, A STUDY FOR A DIFFERENT DATE (SAME PATIENT) APPEARS AND VICE VERSA. A SECOND STUDY HAD ONLY THE LAST NAME OF THE PATIENT AND THE FIRST NAME WAS ADDED LATER. NO PATIENT HARM OR INJURY WAS REPORTED. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14759288 ↗

Other ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.