Data / Medical devices / United States / Merge Healthcare Incorporated
Merge Healthcare Incorporated: FDA-registered device maker in Hartland, WI, United States, 17 510(k) clearances
Merge Healthcare Incorporated is registered with the FDA (registration 2183926) in Hartland, WI, United States. It lists 4 device types. The FDA files 17 510(k) clearances under its listings, the newest dated April 14, 2025. 85 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2183926
- FEI number
- 1000116130
- Address
- 900 Walnut Ridge Dr, Hartland, WI, United States, 53029
- Owner or operator
- Merge Healthcare (10024020)
- Roles
- Manufacturer
- First device listed
- June 22, 2010
- Registered through
- 2026
- Brand names listed
- CADstream, IBM iConnect Access, Merge Cardio, Merge Eye Care PACS, Merge Hemo, Merge Hemo Model RCSV2, Merge OrthoCase, Merge OrthoPACS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Management, Ophthalmic | NFJ | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| Template | HWT | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 14, 2025 | K250301 | Merge Universal Viewer (MUV) | LLZ | Substantially Equivalent | Merge Healthcare Incorporated | accessdata.fda.gov |
| June 21, 2024 | K233326 | Merge Hemo, Model RCSV2 | DQK | Substantially Equivalent | Merge Healthcare Incorporated | accessdata.fda.gov |
| January 26, 2021 | K203104 | IBM iConnect Access | LLZ | Substantially Equivalent | Merge Healthcare Incorporated | accessdata.fda.gov |
| October 17, 2019 | K192455 | Merge PACS | LLZ | Substantially Equivalent | Merge Healthcare Incorporated | accessdata.fda.gov |
| September 20, 2019 | K192276 | Merge Cardio | LLZ | Substantially Equivalent | Merge Healthcare Incorporated | accessdata.fda.gov |
| September 25, 2018 | K182290 | IBM iConnect Access | LLZ | Substantially Equivalent | Merge Healthcare Incorporated | accessdata.fda.gov |
| December 8, 2017 | K173475 | Merge PACS | LLZ | Substantially Equivalent | Merge Healthcare Incorporated | accessdata.fda.gov |
| April 7, 2016 | K152864 | Merge Hemo | DQK | Substantially Equivalent | Merge Healthcare Incorporated | accessdata.fda.gov |
| May 18, 2011 | K110006 | OIS SYMPHONY IMAGE MANAGMENT SYSTEM | NFJ | Substantially Equivalent | Ophthalmic Imaging Systems | accessdata.fda.gov |
| June 23, 2010 | K092915 | CEDARA WEBACCESS, MODEL: 2.4 | LLZ | Substantially Equivalent | Cedara Software Corp. | accessdata.fda.gov |
| November 6, 2009 | K092954 | CADSTREAM VERSION 5 | LLZ | Substantially Equivalent | Confirma, Inc. | accessdata.fda.gov |
| December 17, 2008 | K082421 | HEARTSUITE HEMODYNAMICS 7.10 | DQK | Substantially Equivalent | Emageon, Inc. | accessdata.fda.gov |
| September 5, 2008 | K082144 | AMICAS PACS, VERSION 6.0 | LLZ | Substantially Equivalent | Amicas, Inc. | accessdata.fda.gov |
| December 7, 2005 | K053281 | EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE) | LLZ | Substantially Equivalent | Emageon, Inc. | accessdata.fda.gov |
| August 2, 2005 | K051649 | VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0 | LLZ | Substantially Equivalent | Camtronics Medical Systems | accessdata.fda.gov |
| August 16, 2004 | K041935 | DR SYSTEMS PACS, RELEASE 6.1 | LLZ | Substantially Equivalent | Dr Systems, Inc. | accessdata.fda.gov |
| October 22, 2002 | K022881 | CEDARA I-SOFTVIEW | LLZ | Substantially Equivalent | Cedara Software Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 22, 2026 | 99520 | Class II | Ongoing | Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation | Software issue may cause measurements to be displayed inaccurately. | accessdata.fda.gov |
| June 30, 2026 | 99391 | Class II | Ongoing | Merge PACS, medical imaging diagnostic workstation | Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open. | accessdata.fda.gov |
| August 11, 2025 | 97429 | Class II | Ongoing | 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, di | 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 hig | accessdata.fda.gov |
| February 19, 2025 | 96344 | Class II | Ongoing | 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. | accessdata.fda.gov |
| July 23, 2021 | 88379 | Class II | Terminated | 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. | accessdata.fda.gov |
| August 6, 2020 | 86205 | Class II | Terminated | Merge PACS | Measurements done on the Merge PACS generated MPR s may have incorrect measurements. | accessdata.fda.gov |
| May 8, 2020 | 85633 | Class II | Terminated | 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 a | 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. | accessdata.fda.gov |
| July 11, 2019 | 83300 | Class II | Terminated | 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 | accessdata.fda.gov |
| December 20, 2018 | 81869 | Class II | Terminated | 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 | 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). | accessdata.fda.gov |
| August 14, 2017 | 77811 | Class II | Terminated | 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, | The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation. | accessdata.fda.gov |
| August 7, 2017 | 80570 | Class II | Terminated | 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, | The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation. | accessdata.fda.gov |
| June 13, 2017 | 77627 | Class II | Terminated | 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 s | 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. | accessdata.fda.gov |
| May 24, 2017 | 77271 | Class II | Terminated | 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. | accessdata.fda.gov |
| May 24, 2017 | 77265 | Class II | Terminated | 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. | accessdata.fda.gov |
| May 8, 2017 | 77249 | Class II | Terminated | 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. | accessdata.fda.gov |
| May 8, 2017 | 77248 | Class II | Terminated | 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. | accessdata.fda.gov |
| April 6, 2017 | 76847 | Class II | Terminated | 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. | accessdata.fda.gov |
| January 23, 2017 | 86449 | Class II | Terminated | 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. | accessdata.fda.gov |
| December 9, 2016 | 75602 | Class II | Terminated | 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. | accessdata.fda.gov |
| December 9, 2016 | 75149 | Class II | Terminated | 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 S | Merge received reports of Merge Eye Station being unable to capture images of the eye as expected per the intended use of the product. Merge is recalling product from the field to reduce the risk to patient health. | accessdata.fda.gov |
| October 20, 2016 | 75270 | Class II | Terminated | 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 sourc | A product issues happens for RF projection images. If user measures on RF image,.cal (Calibration) is not displayed and measurement is not correct. The.cal label is not displayed on the projection images after calibration is performed which should be present if the measurement is presented based on Pixel Spacing. | accessdata.fda.gov |
| July 14, 2016 | 75267 | Class II | Terminated | 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, Re | It was reported by a customer that RadSuite images are not appearing as readable images. This product malfunction has the potential to result in delay in care and a possible re-exposure of the patient to radiation (x-ray). | accessdata.fda.gov |
| May 25, 2016 | 75497 | Class II | Terminated | iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI. | Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed. | accessdata.fda.gov |
| April 15, 2016 | 77299 | Class II | Terminated | 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 lab | There are potential issues with results reporting for certain run-based tests. Under certain conditions, the wrong results could inadvertently be verified. | accessdata.fda.gov |
| April 13, 2016 | 77124 | Class II | Terminated | 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. | Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother's MRN, resulting in the wrong fetal measurements getting referenced. | accessdata.fda.gov |
| April 8, 2016 | 76541 | Class II | Terminated | DR Systems Unity PACS software, now known as Merge Unity PACS | Reports were missing demographic header information when they were faxed to referring physicians. | accessdata.fda.gov |
| April 8, 2016 | 76471 | Class II | Terminated | 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 | The software is not adding the correct tomo image. | accessdata.fda.gov |
| April 4, 2016 | 76974 | Class II | Terminated | 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 catheterizatio | Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care. | accessdata.fda.gov |
| April 4, 2016 | 76910 | Class II | Terminated | iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI. | An error message can occur resulting in the prior studies being unavailable for viewing. | accessdata.fda.gov |
| April 4, 2016 | 76859 | Class II | Terminated | 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 | Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording. | accessdata.fda.gov |
| April 4, 2016 | 76851 | Class II | Terminated | 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 | The study is archived but cannot be opened in iConnect Access and cannot send to PACS resulting in comparison studies not being available for physician review to determine the progression of disease. | accessdata.fda.gov |
| April 4, 2016 | 76844 | Class II | Terminated | Merge Eye Station and Merge Eye Care PACS. | During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a newly captured image to be an unwanted file and delete the image permanently. | accessdata.fda.gov |
| April 4, 2016 | 76768 | Class II | Terminated | iConnect Enterprise Archive software. | The versions allow images to be stored without pixel data, resulting in the system not being able to present all the prior studies, which could cause a delay in treatment in determining the progression of disease. | accessdata.fda.gov |
| April 4, 2016 | 76654 | Class II | Terminated | iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare. | The software produced a number of "do not route" exceptions, which may result in potential patient injury or delay in diagnosis or treatment. | accessdata.fda.gov |
| April 4, 2016 | 76594 | Class II | Terminated | Merge PACS software. The firm name on the label is Merge Healthcare. | 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. | accessdata.fda.gov |
| April 4, 2016 | 76590 | Class II | Terminated | Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. | When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure. | accessdata.fda.gov |
| April 4, 2016 | 76447 | Class II | Terminated | Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data. | In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation. | accessdata.fda.gov |
| April 4, 2016 | 76431 | Class II | Terminated | Merge Cardio software. | Cardio study list does not show STAT studies without refreshing. | accessdata.fda.gov |
| April 4, 2016 | 76401 | Class II | Terminated | Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI. | A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt. | accessdata.fda.gov |
| April 4, 2016 | 76312 | Class II | Terminated | Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare. | System locks up which may result in potential patient injury or delay in diagnosis or treatment. | accessdata.fda.gov |
| April 4, 2016 | 76309 | Class II | Terminated | Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU). | The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions. | accessdata.fda.gov |
| April 4, 2016 | 76260 | Class II | Terminated | Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. | Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment. | accessdata.fda.gov |
| March 28, 2016 | 76214 | Class II | Terminated | Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure | There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC. | accessdata.fda.gov |
| March 28, 2016 | 75957 | Class II | Terminated | 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 | If a reader selects Multi-study review prior to the original study completing its loading process and then immediately returns to image review of the original study, it is possible that not all current images will be present for review, which could result in incorrect treatment/diagnosis. | accessdata.fda.gov |
| March 28, 2016 | 75914 | Class II | Terminated | 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. | Eye Station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an Medical Record Number (MRN) | accessdata.fda.gov |
| March 28, 2016 | 75825 | Class II | Terminated | 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 DI | If images are sent without an order in the system, they will be matched with the latest order on the current patient/modality matching potentially resulting in the matching of the report to the incorrect accession number (but still associated to the correct patient). | accessdata.fda.gov |
| March 28, 2016 | 75713 | Class II | Terminated | 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. | Cut lines on the image may present horizontally rather than vertically. | accessdata.fda.gov |
| March 28, 2016 | 75629 | Class II | Terminated | 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 digit | The software did not show unviewed images when the last view was skipped. The physician may potentially misdiagnose when not all images are available for viewing. | accessdata.fda.gov |
| March 10, 2016 | 77086 | Class II | Terminated | The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software. | If the PDM is utilized to output a pressure for computing fractional flow reserve (FFR), the analog output may not reflect the true representation of the selected pressure waveform being provided by the PDM to the Link Assembly which provides the analog output. | accessdata.fda.gov |
| February 9, 2016 | 75027 | Class II | Terminated | Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system. | A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR). | accessdata.fda.gov |
| February 5, 2016 | 74776 | Class II | Terminated | 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. | When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same. | accessdata.fda.gov |
| January 31, 2016 | 74919 | Class II | Terminated | RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. | Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the user has mouse focused on any viewport other than the first viewport. | accessdata.fda.gov |
| January 31, 2016 | 74510 | Class II | Terminated | Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI. | Potential data loss occurs as a result of product archiving not working properly. | accessdata.fda.gov |
| January 30, 2016 | 75334 | Class II | Terminated | Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications | Communication protocols interfacing with the affected software version with some select instruments were not properly handled, preventing data captured by these instructions to be processed by the rest of the LIS software. | accessdata.fda.gov |
| January 30, 2016 | 75239 | Class II | Terminated | CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI. | The software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site starts using PURE filter, the user interface message will not display. This may result in incorrect patient follow-up. | accessdata.fda.gov |
| January 30, 2016 | 75034 | Class II | Terminated | Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system. | Patient information in the header is only found on the first page of the report and not on the subsequent pages. | accessdata.fda.gov |
| January 30, 2016 | 74924 | Class II | Terminated | 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. | Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite. | accessdata.fda.gov |
| January 30, 2016 | 74773 | Class II | Terminated | Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI. | The patient name in the Halo title bar and the thumbnails do not match the name on displayed images. | accessdata.fda.gov |
| January 30, 2016 | 74734 | Class II | Terminated | 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. | Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were ingested in PACS. | accessdata.fda.gov |
| January 30, 2016 | 74651 | Class II | Terminated | 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 | 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. | accessdata.fda.gov |
| January 30, 2016 | 74648 | Class II | Terminated | 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. | Studies coming over via telmed were missing patient's DOB, procedure, and referring physician. | accessdata.fda.gov |
| January 30, 2016 | 74522 | Class II | Terminated | 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 profes | Potential data loss occurs as a result of the software archiving not working properly. | accessdata.fda.gov |
| December 17, 2015 | 72978 | Class II | Terminated | 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 | Potential incorrect Standardized Uptake Values (SUV) measurements in RadSuite. | accessdata.fda.gov |
| November 17, 2015 | 76258 | Class II | Terminated | Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. | The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment. | accessdata.fda.gov |
| October 26, 2015 | 72661 | Class II | Terminated | 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. | The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house. | accessdata.fda.gov |
| October 15, 2015 | 75876 | Class II | Terminated | DR Systems Unity PACS software, now known as Merge Unity PACS software. | The software fails to associate to the correct MG image if there are two images for the same view. | accessdata.fda.gov |
| October 8, 2015 | 75909 | Class II | Terminated | Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI. | Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis or treatment. | accessdata.fda.gov |
| October 1, 2015 | 75714 | Class II | Terminated | 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 | Reporting feature times out after inactivity for more than an hour sending the user back to the study list, which causes all reporting data being entered to be lost. | accessdata.fda.gov |
| September 22, 2015 | 76719 | Class II | Terminated | 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 | Users can merge a device import file with an image study that already has a confirmed report, which may result in including information not present at the time of physician interpretation. | accessdata.fda.gov |
| September 22, 2015 | 76717 | Class II | Terminated | Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI. | For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from different patients with different IPIDs as though they are for the same patient if they all have the first name, last name, and medical record number in common. | accessdata.fda.gov |
| July 23, 2015 | 74846 | Class II | Terminated | 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 o | The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm. | accessdata.fda.gov |
| May 31, 2015 | 75616 | Class II | Terminated | The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software. | Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure. | accessdata.fda.gov |
| April 9, 2015 | 74853 | Class II | Terminated | Merge RadSuite software. Radiological image processing system. | When RadSuite is used with IPID (Issuer of Patient ID) as a part of the "Patient Identifier," it is possible in some circumstances that the demographics of one patient will be applied to a study or studies for another patient. | accessdata.fda.gov |
| March 30, 2015 | 76946 | Class II | Terminated | 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 th | The units may display the alarm "sampling line clogged" after the flow zeroing procedure that is conducted automatically 1 hour after start up. This could result in the potential of a small bias added to the CO2 measurement and affect the alarm notification. | accessdata.fda.gov |
| March 5, 2015 | 75419 | Class II | Terminated | Merge LIS software. | There is a potential for duplicate container numbers to be created for patients. | accessdata.fda.gov |
| January 21, 2015 | 71814 | Class II | Terminated | 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 dat | A system freeze-up of the Merge Hemo system, that included the PHASEIN End Tidal CO2 unit, resulted in the user needing to move the patient to another cath lab. | accessdata.fda.gov |
| September 29, 2014 | 69406 | Class II | Terminated | 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 p | It has been reported that during use, the SpO2 value displayed on the Hemo Monitor may not update to reflect changes in the patient's oxygen value. It is also possible that if using the pulse rate of the SpO2 finger clip to calculate the patient's heart rate, it too may be subject to displaying a stale value. | accessdata.fda.gov |
| August 28, 2014 | 69295 | Class II | Terminated | 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 med | There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studies open and utilizing the thumbnail panel to select multiple series from multiple studies may lead to the selection of an incorrect study. | accessdata.fda.gov |
| April 30, 2014 | 75564 | Class II | Terminated | 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 includ | The application may crash during the cath lab procedure. | accessdata.fda.gov |
| May 6, 2013 | 74815 | Class II | Terminated | RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. | Multiple studies were missing at a customer location that never made it to the archive before watermarking | accessdata.fda.gov |
| November 1, 2012 | 75158 | Class II | Terminated | 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 provi | An incorrect biopsy or missed target could result if the incorrect grid is selected within the application. | accessdata.fda.gov |
| July 2, 2012 | 74577 | Class II | Terminated | Merge HEMO software. | The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7 | accessdata.fda.gov |
| October 28, 2011 | 75425 | Class II | Terminated | Fusion Workstation.; Indicated for the transmission and review of radiological images. | After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values. | accessdata.fda.gov |
| October 19, 2011 | 75161 | Class II | Terminated | 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 provid | Customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting in incorrect patient follow-up. | accessdata.fda.gov |
| January 1, 2008 | 47526 | Not yet classified | Terminated | EVMS (Enterprise Visual Medical System); Picture archiving and communications system; Model Numbers: 5.30.4, 5.30.5, 5.30.6, 5.30.7, 5.40.0 and 7.0.0.1. Emageon, Inc., Hartland, WI 53029. | Miscalculation: The calculation of the standard uptake value does not include the required calibration factor/decay correction factor. The resulting value is incorrectly calculated, which may lead to incorrect interpretation of tissue density. The calculation error exists in both the software and user guide. | accessdata.fda.gov |
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Updated August 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.