Cardiac WorkstationRecalls & reported problems across all models
Philips Medizin Systeme Böblingen GmbH · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
4 open recalls name at least one Cardiac Workstation model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 4
We found 2 models of Cardiac Workstation by Philips Medizin Systeme Böblingen GmbH in the FDA's device registry (GUDID). Together they are named in 18 adverse event reports in the FDA's MAUDE database, received between Apr 15, 2026 and Sep 16, 2026 — classified as 18 malfunctions.
The most frequently reported specific device problem is “High Readings” (7 reports).
4 FDA recall records name at least one of these models by its device identifier, 4 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Cardiac Workstation recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 1, 2026Open, Classified
Device will intermittently provide inaccurate data related to native heart rate.
Z-2956-2026 · Root cause: Software design · Recall details · FDA record ↗
- Jul 1, 2026Open, Classified
Device will intermittently provide inaccurate data related to native heart rate.
Z-2955-2026 · Root cause: Software design · Recall details · FDA record ↗
- Sep 12, 2025Open, 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 ↗
- Sep 12, 2025Open, 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-0165-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported Cardiac Workstation problems
Device problems
- High Readings7
- Incorrect Measurement7
- Imprecise or Erratic Results2
- Incorrect, Inadequate or Imprecise Result or Readings2
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
Cardiac Workstation models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Cardiac Workstation Cardiac Workstation 7000Electrocardiograph2 recalls17 reports
- Cardiac Workstation Cardiac Workstation 5000Electrocardiograph2 recalls1 report
Recent Cardiac Workstation adverse event reports
The 15 most recent reports across all models, 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 ↗
Other Philips Medizin Systeme Böblingen GmbH products
All Philips Medizin Systeme Böblingen GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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