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PageWriter PageWriter TC20 CardiographRecalls & reported problems

Philips Medical Systems Hsg · PageWriter TC20 Cardiograph · Class 2

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884838028784), received between May 16, 2018 and Aug 3, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Data 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Data Problem1
  • Incorrect, Inadequate or Imprecise Result or Readings1
  • No Audible Prompt/Feedback1
  • No Display/Image1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 3, 2026Incorrect, Inadequate or Imprecise Result or Readings

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50123109 ↗
  • MalfunctionApr 6, 2026No Audible Prompt/Feedback

    PHILIPS RECEIVED A COMPLAINT ON THE PAGEWRITER TC20 CARDIOGRAPH INDICATING THE SPEAKER IS NOT FUNCTIONING AND COULD NOT PRODUCE AN AUDIBLE SOUND. THE DEVICE WAS NOT IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24793096 ↗
  • MalfunctionJun 17, 2020Data Problem

    CUSTOMER REPORTED THE UNIT SENDS DATA TO THE SERVER INCORRECTLY, CAUSING A MISMATCH BETWEEN TWO PATIENTS. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10163943 ↗
  • MalfunctionMay 16, 2018No Display/Image

    THE CUSTOMER REPORTED THE SCREEN IS FROZEN. THERE WAS NO REPORT OF ANY ADVERSE IMPACT TO ANY USER OR PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7517674 ↗

Other ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) devices

All ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS) devices →

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