Z-2518-2025Class II

Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product...

Name: Z-2518-2025 Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product...
Creator: Merge Healthcare, Inc.
Published: 2025-08-11
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2025-08-11 / Open, Classified / root cause: manufacturing process

FDA source

Merge Healthcare, Inc. began a recall of 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... on 2025-08-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2518-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-11
Posted: 2025-09-04
Recalling firm: Merge Healthcare Incorporated
Product: 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.
Product code: DQK Computer, Diagnostic, Programmable
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 tag: manufacturing process
FDA 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 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.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2518-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2518-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-04

Product code DQK

K233326Class IIMerge Hemo, Model RCSV2Merge Healthcare Incorporated / cleared 2024-06-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)