ARGUS PB-3000 PB-3000 Var.10, sub-variant: M/IRecalls & reported problems
Schiller AG · "The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a medical device or a medical System (Host System) for acquiring, analysing, and transmission of patient vitals and other pertinent clinical data of following vital date of a patient: ECG and Respiration ECG, heart rate, asystole time, respiration rate and apnoea time for monitoring and diagnostic purpose. IBP The IBP measurement is intended for continuously invasive measurement of a patient’s arterial and/or venous blood pressure in different locations. NIBP The NIBP measurement is intended for non-invasive measure blood pressure with different cuffs in different locations. SpO2 The SpO2 measurement is intended for non-invasive measuring of a patient’s oxygen saturation level and other parameters (e.g. SpCO, SpMet). CO2 and Respiration The CO2 measurement is intended for the non-invasive monitoring of a patient’s in and exhaled carbon dioxide, anaesthesia gases and to provide a respiration rate. Cardiac Output (CO) The Cardiac Output measurement is intended for measuring continuously blood and injected fluid temperature for calculating the current Cardiac Output of a patient in the medical system (Host System). Temperature The Temperature measurement is intended for non-invasive and invasive measurement of a patient’s temperature in different locations." · Class 2
All models of ARGUS PB-3000 (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613365004359), received between Aug 11, 2025 and Aug 11, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Calibration Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K221056); they may or may not involve this specific model.
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
Most reported problems
Device problems
- Calibration Problem1
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.
MalfunctionAug 11, 2025Calibration Problem; Calibration Problem
DURING MERGE HEALTHCARE INCORPORATED (HARTLAND, WI) INTERNAL TESTING OF THE MERGE HEMO, MODEL RCSV2 SYSTEM, IT WAS OBSERVED THAT CERTAIN SCHILLER AG ARGUS PB-3000 PATIENT DATA MODULE (PDM) UNITS TRIGGERED AN ERROR MESSAGE (ERROR CODE: PRESSURE SENSOR DEFECTIVE) WHEN PERFORMING NON-INVASIVE BLOOD PRESSURE (NIBP) MEASUREMENTS WITH AN INITIAL PRESSURE OVER 240 MMHG. THE PROBLEM WAS FURTHER INVESTIGATED AND CONFIRMED BY SCHILLER AG (BAAR, SWITZERLAND), THE ORIGINAL EQUIPMENT MANUFACTURER FOR THE PB-3000. THE SCHILLER AG (BAAR, SWITZERLAND) ARGUS PB-3000 PATIENT DATA MODULE (PDM) IS A VITAL SIGNS MONITORING DEVICE INTENDED TO BE INTEGRATED INTO MERGE HEALTHCARE INCORPORATED'S (HARTLAND, WI) MERGE HEMO, MODEL RCSV2 SYSTEM. MERGE HEALTHCARE INCORPORATED (900 WALNUT RIDGE DRIVE, HARTLAND, WI, 53029 USA; FEI: 1000116130) IS THE INITIAL IMPORTER OF THE ARGUS PB-3000 PDM. NO OTHER COMPONENTS OF THE MERGE HEMO, MODEL RCSV2 SYSTEM ARE AFFECTED. SCHILLER AG (BAAR, SWITZERLAND) HAS DETERMINED THAT WHEN THE INFLATION PRESSURE IS IN THE HIGH-PRESSURE RANGE (>240 MMHG), THE NON-INVASIVE BLOOD PRESSURE (NIBP) MIGHT BECOME NON-FUNCTIONAL. THIS MAY LEAD TO A SHORT DELAY IN DELIVERY OF CARE THAT COULD H
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22779647 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K221056. One submission often covers many models, so check the product and lot details in each record.
- Z-2672-2025 · Aug 8, 2025 · Open, ClassifiedArgus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
Other Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) devices
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- NA PU-621RNihon Kohden Corporation · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)17 deaths1,666 reports
- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)7 recalls8 deaths1,217 reports
- NA PU-681RANihon Kohden Corporation · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)22 deaths1,493 reports
- IntelliVue Multi-Measurement Module X3 IntelliVue X3Philips Medizin Systeme Böblingen GmbH · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall19 deaths1,172 reports
- Patient Information Center IXPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)82 deaths941 reports
- Patient Information Center iXPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)83 deaths814 reports
- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)5 recalls541 reports
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
- 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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