Reported Sep 10, 2025 · Ongoing
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The…
Merge Healthcare, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merge Healthcare, Inc. · 900 Walnut Ridge Dr · Hartland, WI · 53029-8347
Is this the product you have?
Merge HemoModel RCSV2Model/Catalog Number 99-01172-00software versions 11.1 and 11.1.1
- Product DescriptionThe Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices. The system is used for documenting and monitoring patients undergoing diagnostic and interventional catheter-based procedures. The procedures can be performed in the clinical areas of invasive cardiology, interventional radiology, and cardiac electrophysiology
- Lot codes and dates
- Schiller Model Name
ARGUS PB-3000Schiller Model #: 3.921002
- Affected PB-3000 Serial Numbers
84 of 84 codes
7012.0000357012.0000367012.0000377012.0000387012.0000417012.0000427012.0000447012.0000457012.0000467012.0000477012.0000487012.0000507012.0000517012.0000527012.0000537012.0000577012.0000587012.0000597012.0000607012.0000617012.0000627012.0000637012.0000647012.0000657012.0000667012.0000677012.0000687012.0000697012.0000717012.0000727012.0000737012.0000747012.0000757012.0000767012.0000787012.0000797012.0000807012.0000817012.0000827012.0000837012.0000857012.0000877012.0000887012.0000897012.0000907012.0000917012.0000927012.0000937012.0000947012.0000977012.0000987012.0000997012.0001007012.0001017012.0001027012.0001037012.0001047012.0001057012.0001067012.000107
- Schiller Model Name
- Amount recalled
- 84
Where it was sold
Why it was recalled
Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error message on the Merge Hemo Client ( Pressure Sensor Defective ) during non-invasive blood pressure (NIBP) measurements, specifically when the initial inflation pressure is set in the high-pressure range (>240 mmHg). The ARGUS PB-3000 is a vital signs monitoring instrument intended to be integrated into the Merge Hemo System. No other components of the Merge Hemo System are affected.
This product could cause temporary or reversible health problems — stop using it.
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