PlainRecalls

Merge Healthcare, Inc.

Compiled from official public sources by the publisher.

95 recalls on record · Latest: Aug 12, 2026

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Agency notice ledger

Federal filing book Merge Healthcare, Inc. MID-BOOK · SINGLE-AGENCY

#175 of 14,151 · 95 notices · 0.091% archive

  • BOOK 95 notices
  • RANK #175 of 14,151
  • SHARE 0.091% archive
  • AGENCY FDA Devices (95)
  • CAT medical devices
  • CATS 1 category
  • LATEST Aug 12, 2026
  • PHOTO Edwards Lifesciences,…

Nearest notice-volume peer: Edwards Lifesciences, LLC (0 notice gap)

Merge Healthcare, Inc. accounts for about 0.091% of the 104,423-notice archive on 95 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Where Merge Healthcare, Inc. sits among 14,151 recalling firms

Merge Healthcare, Inc. ranks 175th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Merge Healthcare, Inc. vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

95 175th of 14151 higher than 13,975 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Merge Healthcare, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Merge Healthcare, Inc. holds about 0.091% of archive notices alongside 95 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Aug 12, 2026

Merge PACS, medical imaging diagnostic workstation
FDA Devices Moderate Aug 12, 2026

Merge OrthoPACS, medical imaging diagnostic workstation
FDA Devices Moderate Sep 10, 2025

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 procedu
FDA Devices Moderate Mar 26, 2025

VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
FDA Devices Moderate Mar 26, 2025

VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
FDA Devices Moderate Mar 26, 2025

Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system.
FDA Devices Moderate Mar 26, 2025

VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
FDA Devices Moderate Mar 26, 2025

VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
FDA Devices Moderate Sep 8, 2021

Merge Hemo, Software packages 10.2, 10.3, and 10.4
FDA Devices Moderate Nov 4, 2020

Merge LIS
FDA Devices Moderate Sep 16, 2020

Merge PACS
FDA Devices Moderate Jul 1, 2020

Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal
FDA Devices Moderate Jul 31, 2019

Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1
FDA Devices Moderate Jul 31, 2019

Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1
FDA Devices Moderate Mar 6, 2019

The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging System Product Usage: The WinStation Retinal Imager has the same intended use as other fundus cameras. It is specifically used to produce color or black and white images of the retina (fundus imaging) and anterior segement (slit lamp imaging), and fluorescein and ICG angiographic images in a non-invasive manner.
FDA Devices Moderate Aug 8, 2018

Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.
FDA Devices Moderate Jan 24, 2018

Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number 13-00106-00) are two components sold as part of the Merge Hemo System.
FDA Devices Moderate Sep 13, 2017

Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems
FDA Devices Moderate Jul 26, 2017

Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. Merge Eye Care PACS is a software solution using databases for patient demographics, server and other systems of intercommunication with hospital systems via HL7 and DICOM to provide to clinicians a single image viewing and management solution of images imported from various contributing devices throughout the

FDA Devices Moderate Jul 19, 2017

The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
FDA Devices Moderate Jul 5, 2017

Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.
FDA Devices Moderate Jul 5, 2017

SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.
FDA Devices Moderate Jul 5, 2017

MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.
FDA Devices Moderate Jul 5, 2017

MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part Number: HW-HEMO-00075), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output.
FDA Devices Moderate Jul 5, 2017

Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for ordering, managing and reporting a patient s laboratory work, from the time of order entry to the time the laboratory test results are reported.
FDA Devices Moderate Jun 28, 2017

Merge OrthoPACS software.
FDA Devices Moderate Jun 28, 2017

Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
FDA Devices Moderate Jun 21, 2017

Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography
FDA Devices Moderate Jun 21, 2017

Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
FDA Devices Moderate May 31, 2017

Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, and archive clinical information.
FDA Devices Moderate May 10, 2017

Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system.
FDA Devices Moderate Apr 26, 2017

Merge Eye Station and Merge Eye Care PACS.
FDA Devices Moderate Apr 19, 2017

Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
FDA Devices Moderate Apr 19, 2017

iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
FDA Devices Moderate Apr 5, 2017

Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
FDA Devices Moderate Apr 5, 2017

iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data
FDA Devices Moderate Apr 5, 2017

iConnect Enterprise Archive software.
FDA Devices Moderate Mar 29, 2017

Merge Cardio software.
FDA Devices Moderate Mar 29, 2017

Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.
FDA Devices Moderate Mar 29, 2017

Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
FDA Devices Moderate Mar 29, 2017

Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
FDA Devices Moderate Mar 29, 2017

Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.
FDA Devices Moderate Mar 22, 2017

iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.
FDA Devices Moderate Mar 22, 2017

Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.
FDA Devices Moderate Mar 15, 2017

Merge PACS software. The firm name on the label is Merge Healthcare.
FDA Devices Moderate Mar 15, 2017

Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
FDA Devices Moderate Mar 15, 2017

DR Systems Unity PACS software, now known as Merge Unity PACS
FDA Devices Moderate Mar 8, 2017

DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.
FDA Devices Moderate Mar 1, 2017

Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.
FDA Devices Moderate Feb 22, 2017

The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.

Merge Healthcare, Inc. carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Edwards Lifesciences, LLC 95 CooperSurgical, Inc. 97 Philips Respironics, Inc. 93 Stradis Medical, LLC dba Stradis Healthcare 93

Frequently Asked Questions

How many federal recall notices name Merge Healthcare, Inc.? ▼
PlainRecalls indexes 95 distinct federal recall events naming Merge Healthcare, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Merge Healthcare, Inc. sit among other recalling firms? ▼
Merge Healthcare, Inc. ranks #175 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Merge Healthcare, Inc.'s notices? ▼
FDA Devices accounts for 95 of this firm's 95 indexed notices.
What product category dominates Merge Healthcare, Inc.'s filing book? ▼
Filings for Merge Healthcare, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Merge Healthcare, Inc.: 95 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Merge Healthcare, Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026