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Merge Hemo, Model RCSV2

by Merge Healthcare Incorporated United States 510(k)

510(k) K233326 Product code DQK

Overview

Merge Hemo, Model RCSV2 is a computerized hemoglobin A1c monitoring system that utilizes advanced algorithms and machine learning techniques to provide accurate and reliable blood glucose readings. This innovative device enables healthcare professionals to gain valuable insights into patient health, facilitating timely interventions and improved care outcomes.

Regulatory status

as of 25 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK233326 Date21 Jun 2024ClearedStatusActive

Coverage

1 jurisdiction

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  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2518-2025 FDA Class II initiated 11 Aug 2025

    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.

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
DQK
Device Class
Class II
Regulation
21 CFR Part 870.1425
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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See all devices from Merge Healthcare Incorporated →

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K233326 24 fields · synced 22 Oct 2026