Cardiac Workstation Cardiac Workstation 5000Recalls & reported problems
Philips Medizin Systeme Böblingen GmbH · Cardiac Workstation 5000 · Class 2
All models of Cardiac Workstation (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838094826), received between Apr 15, 2026 and Apr 15, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “High Readings” (1 report).
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.
Reports received per month
Recalls naming this device
- Jul 1, 2026Class IIOpen, 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, 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-0165-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- High Readings1
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.
MalfunctionApr 15, 2026High Readings
PHILIPS RECEIVED A COMPLAINT ON THE CARDIAC WORKSTATION 5000 INDICATING THAT THE PATIENT HEART RATE (HR) RECORDED AS HIGH BUT PHYSICALLY THE PATIENT DID NOT HAVE HIGH HR, THE DEVICE WAS IN CLINICAL USE ON A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24887892 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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