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.
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.
The pressure sensor in the Schiller ARGUS PB-3000 module may trigger an error message when the initial blood pressure inflation exceeds 240 mmHg. This can cause inaccurate blood pressure measurements during non-invasive tests, but does not cause physical harm.
Healthcare providers using the Merge Hemo RCSV2 system with specific software versions and Schiller ARGUS PB-3000 patient data modules. Patients undergoing blood pressure monitoring with these systems are at risk of inaccurate readings.
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.
Verify your Merge Hemo software version is not 11.1 or 11.1.1.
Check if your Schiller ARGUS PB-3000 module has a serial number starting with 7012.000035 through 7012.000142.
Schiller AG reported that certain Merge Hemo RCSV2 systems with specific software versions may trigger a 'Pressure Sensor Defective' error when initial blood pressure inflation exceeds 240 mmHg.
No, the error only affects blood pressure readings and does not cause physical harm. The hazard is low risk.
Check for Merge Hemo RCSV2 with model catalog number 99-01172-00 and software versions 11.1 or 11.1.1. Affected Schiller modules have serial numbers starting with 7012.000035 through 7012.000142.
We’ve drafted a message you can send Merge Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2518-2025 — Merge Healthcare Merge Healthcare Hello, I own a Merge Healthcare that is covered by recall Z-2518-2025 from Merge Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
