Merge Healthcare recalls specific RCSV2 models with software versions 11.1 and 11.1.1 due to pressure sensor errors during high inflation blood pressure tests. Affected units may display 'Pressure Sensor Defective' when initial inflation exceeds 240 mmHg.
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.
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📍Recalling firmMerge Healthcare, Inc.900 Walnut Ridge Dr · Hartland, WI 53029-8347
✎ GovInfoNow plain-language explainer
Merge Healthcare is recalling certain RCSV2 hemodynamics monitoring systems with software versions 11.1 and 11.1.1. These units may show a 'Pressure Sensor Defective' error when measuring blood pressure with initial inflation above 240 mmHg, potentially leading to inaccurate readings. Read more at govinfonow.com/recall/51646-merge-hemo-rcsv2-software-11-1-11-1-1-pressure.
“Merge Hemo RCSV2 Software 11.1/11.1.1: Pressure Sensor Error During Blood Pressure Tests.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51646-merge-hemo-rcsv2-software-11-1-11-1-1-pressure. Based on FDA recall #Z-2518-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2518-2025%22&limit=1).
The FDA announced on August 11, 2025, that Merge Healthcare, Inc. is recalling the Merge Hemo system due to a defective patient data module that may trigger an error during blood pressure measurements. The agency issued recall number Z-2518-2025 for the Class II device.
How to tell if you have it
Brand: Merge Healthcare
Product: Merge Hemo, Model RCSV2
Model/Catalog Number: 99-01172-00
Software versions: 11.1 and 11.1.1
Affected component: Schiller ARGUS PB-3000 Patient Data Module, Model #: 3.921002
Units affected: 84
The hazard
According to the FDA, certain Schiller ARGUS PB-3000 units trigger a "Pressure Sensor Defective" error message on the Merge Hemo Client during non-invasive blood pressure measurements when the initial inflation pressure is set in the high-pressure range (>240 mmHg). The record states that no other components of the system are affected.
Context
GovInfoNow's records show Merge Healthcare, Inc. has 11 other recalls on record since June 13, 2017. Other recent recalls of similar products include Hamilton Medical IntelliCuff Recall: Cuff System Leakage Error Risk (May 22, 2026) and Medline Namic Preceptor Manifold Recall: Particulate Risk in Blood Pressure Transducers (March 24, 2026).
How to tell if you have this one
Check for Merge Hemo RCSV2 devices with model catalog number 99-01172-00 and software versions 11.1 or 11.1.1. The affected Schiller ARGUS PB-3000 modules have serial numbers starting with 7012.000035 through 7012.000142.
Brand
Merge Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your Merge Hemo software version is not 11.1 or 11.1.1.
Review Module Serial Numbers
Check if your Schiller ARGUS PB-3000 module has a serial number starting with 7012.000035 through 7012.000142.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 17 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution including in the states of Arizona, Arkansas, California, Florida, Louisiana, Mississippi, North Carolina, North Dakota, Oklahoma, Pennsylvania, Georgia, Illinois, Kentucky, Tennessee, Texas, Washington, and…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Arkansas, California, Florida, Georgia, Illinois, Kentucky, Louisiana, Mississippi, North Carolina, North Dakota, Oklahoma, Pennsylvania, Tennessee, Texas, Washington, Wisconsin.
Recall timeline
FDA published this recall 30 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2518-2025 (August 11, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2518-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.