Merge Healthcare, Inc. recalls Merge Hemo

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 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 available during use of the Merge Hemo system. Actions being taken by Merge Merge Healthcare will contact you to arrange a no-charge inspection of your ARGUS PB-3000 device(s). If the device is affected by this issue, Merge Healthcare will provide a replacement ARGUS PB-3000 and send the affected device to Schiller AG. Please forward this notice to any individuals within your organization that may need to be aware of this notification. Customers should alert any other affiliated parties that may be affected by this Field Safety Corrective Action. Customers experiencing the reported issue should contact Merge Healthcare Support at 1-877-741-5369.

• FDA enforcement recordOfficial FDA database entry for Z-2518-2025
• FDA 510(k) clearance · K233326The device's official FDA premarket clearance record
• FDA device classification · DQKOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1425The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Merge Healthcare, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.