Pressure Sensor Error in Merge Hemo Cardiac Monitoring System Recall
The Merge Hemo hemodynamics monitoring system is recalled due to a pressure sensor defect in its integrated Schiller ARGUS component, which triggers error messages during blood pressure measurements in high-pressure ranges. Eighty-four units distributed nationwide are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall affecting a critical patient monitoring device used during invasive cardiac procedures. While no illnesses or injuries have been reported, the pressure sensor defect creates a risk of harm by preventing accurate blood pressure measurement in high-pressure ranges during high-risk clinical procedures.
Plain-English summary
The Merge Hemo Model RCSV2 is a hemodynamics recording computer system used to monitor, measure, and record blood pressure and other vital physiologic parameters during diagnostic and interventional cardiac procedures. The system is used in invasive cardiology, interventional radiology, and cardiac electrophysiology clinical settings.
Merge Healthcare has been informed that certain units of the integrated Schiller ARGUS PB-3000 Patient Data Module (PDM) contain a pressure sensor defect. When the initial inflation pressure is set in the high-pressure range above 240 mmHg, the defective sensor triggers a "Pressure Sensor Defective" error message on the Merge Hemo Client during non-invasive blood pressure (NIBP) measurements. This error prevents accurate pressure readings at high-pressure settings. No other components of the Merge Hemo System are affected.
The recall affects 84 units distributed nationwide across multiple U.S. states including Arizona, Arkansas, California, Florida, Louisiana, Mississippi, North Carolina, North Dakota, Oklahoma, Pennsylvania, Georgia, Illinois, Kentucky, Tennessee, Texas, Washington, and Wisconsin.
Healthcare facilities using affected Merge Hemo systems should verify their equipment serial numbers against the published list of affected units and contact Merge Healthcare regarding corrective actions. No illnesses or injuries have been reported related to this defect.
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 fl
- Manufacturer
- Merge Healthcare, Inc.
- Hazard
- pressure-sensor-defect
- measurement-error
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.
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