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 Feb 15, 2017

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

Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.
FDA Devices Moderate Feb 15, 2017

Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
FDA Devices Moderate Feb 1, 2017

Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
FDA Devices Moderate Jan 25, 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 Jan 18, 2017

Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior
FDA Devices Moderate Jan 11, 2017

DR Systems Unity PACS software, now known as Merge Unity PACS software.
FDA Devices Moderate Dec 28, 2016

Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
FDA Devices Moderate Dec 21, 2016

Merge Cardio software. 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 Dec 21, 2016

Merge Cardio software. Merge Cardio 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 (waveform) data
FDA Devices Moderate Dec 14, 2016

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 Dec 14, 2016

Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). eFilm Workstation with Modules can be used to communicate, process and display medical images. Users have

FDA Devices Moderate Dec 7, 2016

Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications
FDA Devices Moderate Dec 7, 2016

Merge Hemo software. Merge Hemo 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 CO2, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal CO2. The system is intended for use in hospital cardiac catheterizat
FDA Devices Moderate Nov 30, 2016

Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D surface and volume rendering, Real-time Multi-Planar Reformatting (MPR), Real-time oblique imaging, Integrated image fusion, JPEG2000-based Adaptive Bandwidth Streaming, JPEG and Key Image Note export, Presentation States, Annotation and measurement tools, Automated linking, Display protocols, Enterprise Work
FDA Devices Moderate Nov 23, 2016

iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
FDA Devices Moderate Nov 23, 2016

Merge PACS software. Product Usage: 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 Nov 23, 2016

Merge LIS software.
FDA Devices Moderate Oct 26, 2016

CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
FDA Devices Moderate Oct 26, 2016

CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools.
FDA Devices Moderate Oct 26, 2016

Fusion Workstation.; Indicated for the transmission and review of radiological images.
FDA Devices Moderate Sep 28, 2016

CADstream software. Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools.
FDA Devices Moderate Sep 28, 2016

Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.
FDA Devices Moderate Sep 21, 2016

RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
FDA Devices Moderate Sep 14, 2016

Merge RadSuite software. Radiological image processing system.
FDA Devices Moderate Sep 7, 2016

iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data.
FDA Devices Moderate Sep 7, 2016

Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
FDA Devices Moderate Sep 7, 2016

RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.
FDA Devices Moderate Aug 31, 2016

RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
FDA Devices Moderate Aug 24, 2016

iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
FDA Devices Moderate Aug 24, 2016

iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
FDA Devices Moderate Aug 24, 2016

Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems 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 Aug 17, 2016

Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
FDA Devices Moderate Aug 17, 2016

Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
FDA Devices Moderate Aug 10, 2016

Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
FDA Devices Moderate Aug 10, 2016

Merge HEMO software.
FDA Devices Moderate Aug 10, 2016

Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
FDA Devices Moderate Jul 20, 2016

Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. OfficePACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. OrthoPACS also uses such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the

FDA Devices Moderate Jul 20, 2016

Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.
FDA Devices Moderate Feb 17, 2016

RadSuite, a picture archive and communications system. Model Numbers Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7 HF0473E, 5.30.8, 5.30.8 HF0477E, 5.30.8 HF0490E, 5.30.8 HF0495 SB0508E, 5.30.8 HF0495E, 5.30.8 HF0495E SB504E, 5.30.8 HF0550, 5.30.8 SB0485E, 5.30.8 SB0486E, 5.30
FDA Devices Moderate Jan 6, 2016

Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
FDA Devices Moderate Jan 6, 2016

Merge Cardio with software version 10.1 LA.
FDA Devices Moderate Aug 12, 2015

Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2 (EtCO2) module. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
FDA Devices Moderate Nov 5, 2014

Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the Patient Data Module. This data is then transmitted to the HeartSuite Hemodynamics Hemo Monitor PC via the serial interface. All data can be shown and monitored on the HeartSuite Hemodynamics Hemo Monitor PC.

FDA Devices Moderate Oct 22, 2014

eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that is used for viewing medical images. eFilm Workstation receives digital images and data from various sources (including but not limited to CT,MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Images are stored, c

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