Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2518-2025·Announced 2025-09-10

Hemodynamic recording systems recalled over pressure sensor error during blood pressure measurement

Merge Hemo systems are recalled because certain Schiller ARGUS PB-3000 patient data modules trigger a Pressure Sensor Defective error during non-invasive blood pressure measurement above 240 mmHg. 84 units are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Rubric level 2 covers precautionary recalls; the stated effect is an error message during a specific measurement setting, with no patient harm described.

Plain-English summary

The Merge Hemo, model RCSV2, model and catalog number 99-01172-00, software versions 11.1 and 11.1.1, is being recalled. The device is a hemodynamics recording computer system that monitors, measures, displays, records and stores vital signs data. Affected Schiller ARGUS PB-3000 serial numbers are listed in the recall notice. The recall covers 84 units distributed nationwide in the United States.

Merge Healthcare was informed by Schiller AG of an issue with the Schiller ARGUS PB-3000 Patient Data Module, where certain units trigger an error message on the Merge Hemo Client reading Pressure Sensor Defective during non-invasive blood pressure measurements, specifically when the initial inflation pressure is set in the high-pressure range above 240 mmHg. The notice states no other components of the Merge Hemo System are affected. The FDA classified the action as Class II.

Hospitals operating these systems should follow the manufacturer's instructions for affected patient data modules.

The recalled product

Product: Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood…
Manufacturer: Merge Healthcare, Inc.
Category: Medical Device — Patient Monitoring
Hazard: sensor-error
blood-pressure
patient-monitoring
class-ii
Affected units: 84

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Schiller Model Name: ARGUS PB-3000
Schiller Model #: 3.921002
Affected PB-3000 Serial Numbers: 7012.000035
7012.000036
7012.000037
7012.000038
7012.000041
7012.000042
7012.000044
7012.000045
7012.000046
7012.000047
7012.000048
7012.000050
7012.000051
7012.000052
7012.000053
7012.000057
7012.000058
7012.000059

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Same manufacturer · Merge Healthcare, Inc.

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