Recall Z-2518-2025 ยท DQK Computer, Diagnostic, Programmable
Merge Healthcare, Inc.
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 flow parameters based on the output from one or more electrodes, transducers, or measuring devices. The system is used for
| Date | Sep 4, 2025 (initiated Aug 11, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | Merge Healthcare issued a Field Safety Corrective Action notice to its consignees on 08/12/2025 via email. The notice explained the issue with the device, potential risk to patients, and requested the following actions: Immediate actions to reduce risk to patients For customers using affected versions of Merge Hemo, the following action should be taken to mitigate the risk of non-invasive blood pressure (NIBP) becoming non-functional in the high-pressure range (>240 mmHg): " Ensure an alternative method for determining NIBP, such as a sphygmomanometer or other NIBP measuring device, is ava |
| Quantity | 84 |
| 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 Wisconsin. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K233326 | Merge Hemo, Model RCSV2 Merge Healthcare Incorporated, Jun 21, 2024 |