{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "215580", "product_res_number": "Z-2518-2025", "event_date_initiated": "2025-08-11", "event_date_posted": "2025-09-04", "recall_status": "Open, Classified", "res_event_number": "97429", "product_code": "DQK", "k_numbers": [ "K233326" ], "product_description": "Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1\nProduct 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 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.", "code_info": "Schiller Model Name: ARGUS PB-3000, Schiller Model #: 3.921002, \nAffected PB-3000 Serial Numbers: 7012.000035, 7012.000036, 7012.000037, 7012.000038, 7012.000041, 7012.000042, 7012.000044, 7012.000045, 7012.000046, 7012.000047, 7012.000048, 7012.000050, 7012.000051, 7012.000052, 7012.000053, 7012.000057, 7012.000058, 7012.000059, 7012.000060, 7012.000061, 7012.000062, 7012.000063, 7012.000064, 7012.000065, 7012.000066, 7012.000067, 7012.000068, 7012.000069, 7012.000071, 7012.000072, 7012.000073, 7012.000074, 7012.000075, 7012.000076, 7012.000078, 7012.000079, 7012.000080, 7012.000081, 7012.000082, 7012.000083, 7012.000085, 7012.000087, 7012.000088, 7012.000089, 7012.000090, 7012.000091, 7012.000092, 7012.000093, 7012.000094, 7012.000097, 7012.000098, 7012.000099, 7012.000100, 7012.000101, 7012.000102, 7012.000103, 7012.000104, 7012.000105, 7012.000106, 7012.000107, 7012.000108, 7012.000109, 7012.000110, 7012.000111, 7012.000112, 7012.000113, 7012.000114, 7012.000115, 7012.000116, 7012.000117, 7012.000118, 7012.000119, 7012.000120, 7012.000123, 7012.000124, 7012.000125, 7012.000126, 7012.000137, 7012.000138, 7012.000140, 7012.000141, 7012.000142, 7012.000157, 7012.000176", "firm_fei_number": "1000116130", "recalling_firm": "Merge Healthcare, Inc.", "address_1": "900 Walnut Ridge Dr", "city": "Hartland", "state": "WI", "postal_code": "53029-8347", "additional_info_contact": "Nadia Marchant\n+1-262-3670700", "reason_for_recall": "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_description": "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: \nImmediate actions to reduce risk to patients\nFor 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):\n \" 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. \nActions being taken by Merge\nMerge 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.\nPlease 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.\nCustomers experiencing the reported issue should contact Merge Healthcare Support at 1-877-741-5369.", "product_quantity": "84", "distribution_pattern": "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.", "openfda": { "k_number": [ "K250749", "K232616", "K031970", "K110878", "K201060", "K142681", "K254089", "K101667", "K233943", "K111200", "K071818", "K974192", "K183128", "K252978", "K930806", "K211546", "K213972", "K002137", "K032513", "K093942", "K161240", "K760767", "K252238", "K241197", "K150493", "K003362", "K191392", "K053194", "K212490", "K103782", "K112688", "K883152", "K252013", "K020863", "K210543", "K011903", "K231035", "K913193", "K031000", "K023380", "K201921", 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