ARGUS PB-3000Recalls & reported problems across all models

We found 6 models of ARGUS PB-3000 by Schiller AG in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, 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 FDA recall record name at least one of these models by its device identifier, 1 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

ARGUS PB-3000 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.

1. Aug 8, 2025Open, Classified

   Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in the high-pressure range.

   Z-2672-2025 · Root cause: Nonconforming Material/Component · names 5 of these models · Recall details · FDA record ↗

Most reported ARGUS PB-3000 problems

ARGUS PB-3000 models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ARGUS PB-3000 PB-3000 Var.7, sub-variant: SAG

  Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
  1 recall0 reports
• ARGUS PB-3000 PB-3000 Var.7, sub-variant: M/I

  Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
  1 recall0 reports
• ARGUS PB-3000 PB-3000 Var.7, sub-variant: C

  Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
  1 recall0 reports
• ARGUS PB-3000 PB-3000 Var.8, sub-variant: Q

  Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
  1 recall0 reports
• ARGUS PB-3000 PB-3000 Var.9, sub-variant: Q

  Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
  1 recall0 reports
• ARGUS PB-3000 PB-3000 Var.10, sub-variant: M/I

  Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
  1 report

Recent ARGUS PB-3000 adverse event reports

The 1 most recent reports across all models, 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 ↗