The Recall Desk

Manufacturer

Merge Healthcare, Inc.

96 recalls in our database name Merge Healthcare, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
96
Critical
0
Severe
3
Most recent
2026-09-02

Of the 96 recalls from Merge Healthcare, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (3%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–75 of 96

  • HighFDA (Devices)·Z-1203-2017·2017-02-22

    Merge Healthcare Recalls Schiller PB 1000 Blood Pressure Pumps

    Merge Healthcare is recalling Schiller PB 1000 blood pressure pumps because insufficient voltage causes them to fail before reaching adequate pressure.

    Product
    The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1176-2017·2017-02-15

    Merge PACS Software Recalled for Potential Incorrect Patient Image Display

    Merge Healthcare is recalling Merge PACS software version 7.0.1 because it may display incorrect patient images, potentially delaying diagnosis or treatment.

    Product
    Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-1180-2017·2017-02-15

    Merge RadSuite software recalled due to incorrect pixel value data

    Merge Healthcare is recalling RadSuite software version V8.30.7.8 because incorrect pixel values may lead to patient injury or delayed diagnosis.

    Product
    Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1142-2017·2017-02-15

    Merge Healthcare Recalls Eye Station Imaging Devices Due to Capture Failures

    Merge Healthcare is recalling 182 Eye Station capture stations because they may fail to capture eye images as intended, posing a risk to patient health.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1091-2017·2017-02-01

    Merge Hemo software recall due to potential connection issues

    Merge Healthcare is recalling Merge Hemo software versions 6.10 through 9.40.3 because the Hemo Monitor may fail to communicate with the Client PC during power-up.

    Product
    Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1046-2017·2017-01-25

    Merge Cardio software recalled for potential image loading errors

    Merge Healthcare is recalling Merge Cardio software versions 9.0 through 10.1.2 because a specific user action may cause images to be missing, potentially leading to incorrect diagnosis or treatment.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1017-2017·2017-01-18

    Merge Eye Station Software Recalled for Potential Data Deletion

    Merge Healthcare is recalling Merge Eye Station software versions 11.6.0 and prior due to a risk of accidental patient record deletion.

    Product
    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
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0939-2017·2017-01-11

    Merge Unity PACS Software Recalled for Incorrect Mammogram Image Association

    Merge Healthcare is recalling Unity PACS software version 11.0 because it may fail to associate the correct mammogram image when two images exist for the same view.

    Product
    DR Systems Unity PACS software, now known as Merge Unity PACS software.
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0878-2017·2016-12-28

    Merge OrthoCase software recall due to measurement errors

    Merge Healthcare is recalling OrthoCase software because measurements change after saving, potentially causing patient injury or delayed diagnosis.

    Product
    Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0729-2017·2016-12-21

    Merge Cardio software recalled for potential report matching errors

    Merge Healthcare is recalling Merge Cardio software versions 8.30.0 through 10.1.1 because images sent without an order may be matched to the wrong accession number.

    Product
    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 characte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0730-2017·2016-12-21

    Merge Cardio software recall for data loss during inactivity

    Merge Healthcare is recalling Merge Cardio software versions 10.1 and 10.1.1 because the reporting feature times out after one hour of inactivity, causing data loss.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0707-2017·2016-12-14

    Merge Healthcare Recalls eFilm Workstation Software Due to Measurement Errors

    Merge Healthcare is recalling eFilm Workstation software versions 2.1 through 4.1 because RF projection images may display incorrect measurements without a calibration indicator.

    Product
    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, com
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0726-2017·2016-12-14

    Merge PACS software recall for horizontal image cut lines

    Merge Healthcare is recalling Merge PACS software because image cut lines may appear horizontally instead of vertically.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0665-2017·2016-12-07

    Merge Healthcare Recalls Hemo Software Due to Potential Application Crashes

    Merge Healthcare is recalling Merge Hemo software versions 9.10 through 9.40.2 because the application may crash during cardiac catheterization procedures.

    Product
    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, NIB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0664-2017·2016-12-07

    Merge FlexConnect Software Recalled for Data Processing Errors

    Merge Healthcare is recalling Merge FlexConnect software version 1.0 because communication protocols were not properly handled, preventing data from being processed by the LIS software.

    Product
    Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0614-2017·2016-11-30

    Merge Healthcare Recalls RadSuite Software Due to Image Display Malfunction

    Merge Healthcare is recalling RadSuite software versions 8.30.7.8 through 8.31 because images may not appear readable, potentially delaying care or causing patient re-exposure to radiation.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0599-2017·2016-11-23

    Merge PACS software recall due to unviewed image display defect

    Merge Healthcare is recalling Merge PACS software because it may fail to display unviewed images, potentially leading to physician misdiagnosis.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0611-2017·2016-11-23

    Merge Healthcare Recalls iConnect Access Software Due to Display Error

    Merge Healthcare is recalling iConnect Access software versions 3.0.1, 3.1, and 3.2 because the software displayed incorrect prior reports when viewing multiple studies.

    Product
    iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0118-2017·2016-10-26

    Merge Healthcare Recalls CADstream Software Due to Incorrect Patient Follow-up

    Merge Healthcare is recalling CADstream software versions prior to 5.2.6 because changes to study protocols may result in incorrect patient follow-up.

    Product
    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 tool
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0137-2017·2016-10-26

    Merge Healthcare CADstream software recall for missing PURE filter message

    Merge Healthcare is recalling CADstream software versions prior to 5.2.9 because the PURE filter user interface message may not display, potentially leading to incorrect patient follow-up.

    Product
    CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2871-2016·2016-09-28

    Merge Healthcare Recalls CADstream MRI Software Due to Grid Selection Error

    Merge Healthcare is recalling CADstream software versions 4.1.3 and prior because an incorrect grid selection could lead to an incorrect biopsy or missed target during MRI analysis.

    Product
    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 tool
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2865-2016·2016-09-28

    Merge Cardio software recall for missing patient information on report pages

    Merge Healthcare is recalling Merge Cardio software version 10.1 because patient information is missing from subsequent report pages.

    Product
    Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2796-2016·2016-09-21

    Merge Healthcare Recalls RadSuite Software Due to Missing Studies

    Merge Healthcare is recalling RadSuite software versions where studies may be missing from archives before watermarking.

    Product
    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide