Class II Recall

Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The M

Summary

The FDA issued a Class II for Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11. by Merge Healthcare, Inc.. 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 cert.

Details

Source

Device Recall

External ID

Z-2518-2025

Action Date

2025-09-10

Status

Ongoing

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.

Lot/Code Info: 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

Quantity Affected: 84

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

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-08-11

Company

Merge Healthcare, Inc.

Hartland, WI

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 258 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Merge Healthcare, Inc. has 7 FDA actions in our database, including 7 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Merge Healthcare, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Merge Healthcare, Inc. have FDA actions?

Merge Healthcare, Inc. has 7 FDA actions in our database, including 7 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-2518-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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