Merge Healthcare Incorporated
Hartland, WI, US
Merge Healthcare Incorporated appears in FDA device records in Hartland, WI. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 97 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Merge Healthcare Incorporated carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Emageon, Inc.510(k), recall
- Merge Healthcare, Inc.enforcement report, recall
510(k) clearance history
FDA records hold 10 510(k) clearances for Merge Healthcare Incorporated between 2005 and 2025. The busiest year on record is 2019, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2008 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| 2021 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250301 | Merge Universal Viewer (MUV) | LLZ | Substantially Equivalent | |
| K233326 | Merge Hemo, Model RCSV2 | DQK | Substantially Equivalent | |
| K203104 | IBM iConnect Access | LLZ | Substantially Equivalent | |
| K192455 | Merge PACS | LLZ | Substantially Equivalent | |
| K192276 | Merge Cardio | LLZ | Substantially Equivalent | |
| K182290 | IBM iConnect Access | LLZ | Substantially Equivalent | |
| K173475 | Merge PACS | LLZ | Substantially Equivalent | |
| K152864 | Merge Hemo | DQK | Substantially Equivalent | |
| K082421 | HEARTSUITE HEMODYNAMICS 7.10 | DQK | Substantially Equivalent | |
| K053281 | EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE) | LLZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2183926 | 1000116130 | Merge Healthcare Incorporated | 900 Walnut Ridge Dr, Hartland, WI 53029 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
Showing 25 of 97| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3004-2026 | Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation | Software issue may cause measurements to be displayed inaccurately. | Class II | Open, Classified | |
| Z-2875-2026 | Merge OrthoPACS, medical imaging diagnostic workstation | Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open. | Class II | Open, Classified | |
| Z-2874-2026 | Merge PACS, medical imaging diagnostic workstation | Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open. | Class II | Open, Classified | |
| Z-2518-2025 | 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 procedures. The procedures can be performed in the clinical areas of invasive cardiology, interventional radiology, and cardiac electrophysiology. | 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. | Class II | Open, Classified | |
| Z-1402-2025 | 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. | When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report. | Class II | Open, Classified | |
| Z-1401-2025 | 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. | When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report. | Class II | Open, Classified | |
| Z-1400-2025 | 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. | When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report. | Class II | Open, Classified | |
| Z-1399-2025 | 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. | When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report. | Class II | Open, Classified | |
| Z-1398-2025 | 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. | When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report. | Class II | Open, Classified | |
| Z-2387-2021 | Merge Hemo, Software packages 10.2, 10.3, and 10.4 | The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface. | Class II | Terminated | |
| Z-2944-2020 | Merge PACS | Measurements done on the Merge PACS generated MPR s may have incorrect measurements. | Class II | Terminated | |
| Z-2403-2020 | 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 (waveform) data. | An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score calculation. The error may reduce the sensitivity of the Z-Score in detecting an abnormality resulting in a false negative. | Class II | Terminated | |
| Z-2063-2019 | Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1 | Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae). | Class II | Terminated | |
| Z-2062-2019 | Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1 | Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae). | Class II | Terminated | |
| Z-0939-2019 | 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. | Certain configurations of Merge Eye Station hardware may result in electrical output that exceeds the allowable limits for medical devices. Leakage current was found to exceed allowable limits in earth leakage current, touch current in a single fault condition (of open ground) and patient leakage current in a single fault condition (of open ground). | Class II | Terminated | |
| Z-3105-2017 | 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 | The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation. | Class II | Terminated | |
| Z-2566-2018 | 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. | The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation. | Class II | Terminated | |
| Z-2754-2017 | 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 clinical environment. Merge Eye Care PACS provides the ability to review data from any network-connected computer, and is protected by appropriate security login which permits only authorized user access. Symphony uses 256 bit or greater encryption via secure socket layer (SSL) to assure a network environment which is secure. | When the user has not set up any user preference on the sorting order to render the study images (OS/OD/etc.) and reports, the ECP may get an incorrect study index. If the user attempts to delete an image, ECP may then read that image as OS when it is, in fact, OD. | Class II | Terminated | |
| Z-2601-2017 | Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI. | Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server. | Class II | Terminated | |
| Z-2620-2017 | Merge OrthoPACS software. | A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations. | Class II | Terminated | |
| Z-2591-2017 | 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 | When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis. | Class II | Terminated | |
| Z-2590-2017 | Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. | Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing. | Class II | Terminated | |
| Z-0350-2018 | 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. | Merge is conducting a hardware recall (replacement) of Fellows "Mighty 8" Power Strip and TrippLite Power Strip due to overheat of input resistor causing the power strip to smoke. | Class II | Terminated | |
| Z-0289-2021 | Merge LIS | A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report. | Class II | Terminated | |
| Z-1017-2017 | 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 | This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an Eye Station user. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain