Z-2518-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 10, 2025
- Initiation Date
- August 11, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 84
Product Description
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 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.
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.
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.
Code Information
Schiller Model Name: ARGUS PB-3000, Schiller Model #: 3.921002, Affected 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