Cardiac Workstation Cardiac Workstation 7000Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00884838094833), received between Apr 22, 2026 and Sep 16, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (7 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Jul 1, 2026Class IIOpen, Classified

   Device will intermittently provide inaccurate data related to native heart rate.

   Z-2956-2026 · Root cause: Software design · Recall details · FDA record ↗

2. Sep 12, 2025Class IIOpen, Classified

   Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.

   Z-0166-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Incorrect Measurement

  It was reported that the heart rate reading is inaccurate. It is unknown if the device was in use on a patient. There was no report of patient or user harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785956 ↗
• MalfunctionSep 15, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50781777 ↗
• MalfunctionSep 10, 2026Incorrect Measurement

  Philips received a complaint on a Cardiac Workstation 7000 indicating that there was an issue with pins showing inaccuracy in functionality. The device was not in clinical use at the time of the event. No adverse event was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722082 ↗
• MalfunctionSep 4, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50615881 ↗
• MalfunctionSep 4, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614454 ↗
• MalfunctionSep 4, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614451 ↗
• MalfunctionSep 4, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614449 ↗
• MalfunctionSep 4, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50611867 ↗
• MalfunctionSep 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50609831 ↗
• MalfunctionAug 28, 2026High Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50500196 ↗
• MalfunctionAug 25, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  It was reported that there is a false negative in Atrial flutter and Sinus rhythm interpretation. The device was in use on a patient at the time of the event. There was no adverse event reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50427057 ↗
• MalfunctionAug 14, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50252352 ↗
• MalfunctionJul 28, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50057760 ↗
• MalfunctionJun 11, 2026Imprecise or Erratic Results

  PHILIPS RECEIVED A COMPLAINT ON A CARDIAC WORKSTATION 7000 INDICATING THAT THE PIM MODULE IS NOT RECORDING THE ECG PROPERLY. THIS WAS IDENTIFIED DURING TESTING/QUALITY CONTROL. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25476801 ↗
• MalfunctionMay 21, 2026Incorrect Measurement

  PHILIPS RECEIVED A COMPLAINT ON THE CARDIAC WORKSTATION 7000 INDICATING THAT THE DEVICE WAS GIVING INACCURATE HEART RATE DATA. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT, AND THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25244750 ↗
• MalfunctionMay 14, 2026Imprecise or Erratic Results

  PHILIPS RECEIVED A COMPLAINT ON THE CARDIAC WORKSTATION 7000 INDICATING THAT THE HEART RATE IS ABNORMAL. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT, AND THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25172898 ↗
• MalfunctionApr 22, 2026Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE DEVICE GAVE INACCURATE READINGS. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24956216 ↗