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IECG B.01.00Recalls & reported problems

Philips Medical Systems Hsg · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884838032408), received between Aug 16, 2019 and Jun 15, 2020 — classified as 2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available1
  • Data Problem1

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 15, 2020Appropriate Device Problem Term/Code Not Available

    CUSTOMER REPORTED AN EKG WAS UNDER THE WRONG PATIENT. THE DEVICE WAS NOT IN USE ON A PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10153715 ↗
  • MalfunctionAug 16, 2019Data Problem

    CUSTOMER REPORTED AN UNKNOWN HEART RATE DATA ISSUE. 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 8900577 ↗

Other COMPUTER, DIAGNOSTIC, PROGRAMMABLE devices

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Sources and updates

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