Recall Register

Merge Healthcare, Inc.: FDA recalls

FDA enforcement reports name Merge Healthcare, Inc. as the recalling firm in 84 events. The events have 96 product records. The recalls started from 2011 to 2026. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

84 events, newest first.

FDA enforcement events of Merge Healthcare, Inc.
InitiatedProduct (first record)TypeClassRecordsStatus
22 Jul 2026Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstationDeviceClass II1Ongoing
30 Jun 2026Merge PACS, medical imaging diagnostic workstationDeviceClass II2Ongoing
11 Aug 2025Merge 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…DeviceClass II1Ongoing
19 Feb 2025VERICIS, 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.DeviceClass II5Ongoing
23 Jul 2021Merge Hemo, Software packages 10.2, 10.3, and 10.4DeviceClass II1Terminated
6 Aug 2020Merge PACSDeviceClass II1Terminated
8 May 2020Merge 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,…DeviceClass II1Terminated
11 Jul 2019Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1DeviceClass II2Terminated
20 Dec 2018The 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…DeviceClass II1Terminated
14 Aug 2017Merge 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…DeviceClass II1Terminated
7 Aug 2017Merge 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…DeviceClass II1Terminated
13 Jun 2017Merge 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…DeviceClass II1Terminated
24 May 2017Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.DeviceClass II1Terminated
24 May 2017Merge OrthoPACS software.DeviceClass II1Terminated
8 May 2017Merge 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 mammographyDeviceClass II1Terminated
8 May 2017Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.DeviceClass II1Terminated
6 Apr 2017Fellows "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.DeviceClass II1Terminated
23 Jan 2017Merge LISDeviceClass II1Terminated
9 Dec 2016Merge 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.DeviceClass II1Terminated
9 Dec 2016Merge 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 priorDeviceClass II1Terminated
20 Oct 2016Merge, 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,…DeviceClass II1Terminated
14 Jul 2016Merge 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,…DeviceClass II1Terminated
25 May 2016iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.DeviceClass II1Terminated
15 Apr 2016Merge 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.DeviceClass II1Terminated
13 Apr 2016Merge 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.DeviceClass II1Terminated
8 Apr 2016DR 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.DeviceClass II1Terminated
8 Apr 2016DR Systems Unity PACS software, now known as Merge Unity PACSDeviceClass II1Terminated
4 Apr 2016iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.DeviceClass II1Terminated
4 Apr 2016Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.DeviceClass II1Terminated
4 Apr 2016iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.DeviceClass II1Terminated
4 Apr 2016Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.DeviceClass II1Terminated
4 Apr 2016Merge 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 procedureDeviceClass II1Terminated
4 Apr 2016Merge Eye Station and Merge Eye Care PACS.DeviceClass II1Terminated
4 Apr 2016SpO2 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,…DeviceClass II4Terminated
4 Apr 2016Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.DeviceClass II1Terminated
4 Apr 2016Merge PACS software. The firm name on the label is Merge Healthcare.DeviceClass II1Terminated
4 Apr 2016Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.DeviceClass II1Terminated
4 Apr 2016iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and dataDeviceClass II1Terminated
4 Apr 2016Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).DeviceClass II1Terminated
4 Apr 2016iConnect Enterprise Archive software.DeviceClass II1Terminated
4 Apr 2016Merge Cardio software.DeviceClass II1Terminated
4 Apr 2016Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.DeviceClass II1Terminated
28 Mar 2016Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedureDeviceClass II1Terminated
28 Mar 2016Merge 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.DeviceClass II1Terminated
28 Mar 2016Merge 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.DeviceClass II1Terminated
28 Mar 2016Merge 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.DeviceClass II1Terminated
28 Mar 2016Merge 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…DeviceClass II1Terminated
28 Mar 2016Merge 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…DeviceClass II1Terminated
10 Mar 2016The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.DeviceClass II1Terminated
9 Feb 2016Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.DeviceClass II1Terminated
5 Feb 2016Merge 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.DeviceClass II1Terminated
31 Jan 2016RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.DeviceClass II1Terminated
31 Jan 2016Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.DeviceClass II1Terminated
30 Jan 2016iConnect 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.DeviceClass II2Terminated
30 Jan 2016CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.DeviceClass II1Terminated
30 Jan 2016RadSuite 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.DeviceClass II2Terminated
30 Jan 2016Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.DeviceClass II1Terminated
30 Jan 2016Merge 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.DeviceClass II1Terminated
30 Jan 2016Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applicationsDeviceClass II1Terminated
30 Jan 2016Merge 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.DeviceClass II1Terminated
30 Jan 2016Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.DeviceClass II1Terminated
30 Jan 2016Merge 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…DeviceClass II1Terminated
17 Dec 2015RadSuite, 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,…DeviceClass II1Terminated
17 Nov 2015Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.DeviceClass II1Terminated
26 Oct 2015Merge 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.DeviceClass II2Terminated
15 Oct 2015DR Systems Unity PACS software, now known as Merge Unity PACS software.DeviceClass II1Terminated
8 Oct 2015Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.DeviceClass II1Terminated
1 Oct 2015Merge 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…DeviceClass II1Terminated
22 Sep 2015Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.DeviceClass II1Terminated
22 Sep 2015Merge 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…DeviceClass II1Terminated
23 Jul 2015Merge 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.DeviceClass II1Terminated
31 May 2015The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.DeviceClass II1Terminated
9 Apr 2015Merge RadSuite software. Radiological image processing system.DeviceClass II1Terminated
30 Mar 2015Schiller 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.DeviceClass II1Terminated
5 Mar 2015Merge LIS software.DeviceClass II1Terminated
21 Jan 2015Merge 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.DeviceClass II1Terminated
29 Sep 2014Merge 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…DeviceClass II1Terminated
28 Aug 2014eFilm 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…DeviceClass II1Terminated
30 Apr 2014Merge 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…DeviceClass II1Terminated
6 May 2013RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.DeviceClass II1Terminated
1 Nov 2012CADstream 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.DeviceClass II1Terminated
2 Jul 2012Merge HEMO software.DeviceClass II1Terminated
28 Oct 2011Fusion Workstation.; Indicated for the transmission and review of radiological images.DeviceClass II1Terminated
19 Oct 2011CADstream 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.DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Merge Healthcare, Inc.: events for each product type
TypeEvents
Device84
Merge Healthcare, Inc.: events in each class
ClassEvents
Class II84
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
4

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Merge Healthcare, Inc., by the year that the recall started. The largest year is 2016, with 44 events.

Official channels

Cite this page

Recall Register. Merge Healthcare, Inc.: FDA recalls. https://recallregister.com/firm/merge-healthcare-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
WI

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Merge Healthcare, Inc. have?
Class II: 84 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Merge Healthcare, Inc.?
FDA event 99520, which the firm started on 22 Jul 2026. The first product in the record is: Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
How many FDA recalls of Merge Healthcare, Inc. have the status Ongoing?
4 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.