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.

26–50 of 96

  • ModerateFDA (Devices)·Z-2643-2017·2017-07-05

    Merge Healthcare Recalls MasimoSET SpO2 Sensors for Display Issues

    Merge Healthcare is recalling 65 MasimoSET LNOP DCI adult SpO2 reusable sensors because cables may stop displaying patient SpO2, causing slight delays in care.

    Product
    MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part Number: HW-HEMO-00075), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2601-2017·2017-06-28

    Merge OrthoPACS software recalled due to data propagation failures

    Merge Healthcare is recalling specific versions of Merge OrthoPACS software because studies may fail to transfer or import correctly between servers.

    Product
    Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2620-2017·2017-06-28

    Merge OrthoPACS Software Recalled for Annotation Display Error

    Merge Healthcare is recalling Merge OrthoPACS software versions 6.6, 6.6.1, and 6.6.2 because prior studies may fail to display annotations.

    Product
    Merge OrthoPACS software.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2590-2017·2017-06-21

    Merge PACS Software Recalled for Potential Image Display Defect

    Merge Healthcare is recalling specific versions of Merge PACS software because unviewed images may not display correctly, posing a risk of physician misdiagnosis.

    Product
    Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2591-2017·2017-06-21

    Merge Healthcare Recalls Merge PACS Software Due to Image Display Defect

    Merge Healthcare is recalling specific versions of Merge PACS software because a display defect may cause image lines to shift, potentially leading to physician misdiagnosis.

    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-2123-2017·2017-05-31

    Merge Cardio software recalled for incorrect fetal measurement data retrieval

    Merge Healthcare is recalling Merge Cardio software versions 10.0 through 10.1.2 because the software may display incorrect fetal measurements by pulling data from prior pregnancies.

    Product
    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.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1923-2017·2017-05-10

    Merge Healthcare Recalls Schiller CO2 Sensors Due to Alarm Bias

    Merge Healthcare is recalling 23 Schiller CO2 sensors that may display false clogging alarms, potentially adding bias to CO2 measurements and affecting alarm notifications.

    Product
    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 the Merge Hemo system.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1828-2017·2017-04-26

    Merge Healthcare Recalls Eye Station and Eye Care PACS Software

    Merge Healthcare is recalling Eye Station and Eye Care PACS software because antivirus programs may permanently delete newly captured medical images.

    Product
    Merge Eye Station and Merge Eye Care PACS.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1778-2017·2017-04-19

    Merge Hemo software recall for incorrect FFR results display

    Merge Healthcare is recalling Merge Hemo software versions 9.10.0 through 9.40.0 because they may display incorrect Fractional Flow Reserve values during cardiac catheterization.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1762-2017·2017-04-19

    Merge Healthcare Recalls iConnect Enterprise Archive Software Due to Display Error

    Merge Healthcare is recalling iConnect Enterprise Archive software because an error message can prevent users from viewing prior studies. The recall affects 333 sites nationwide and internationally.

    Product
    iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1697-2017·2017-04-05

    Merge Healthcare Recalls iConnect Enterprise Archive Software Due to Data Access Issues

    Merge Healthcare is recalling iConnect Enterprise Archive software because archived studies cannot be opened or sent to PACS, preventing physicians from reviewing comparison studies.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1681-2017·2017-04-05

    Merge Eye Care Systems Software Recall Due to Image Acquisition Failure

    Merge Healthcare is recalling Eye Care Systems software because incompatible versions prevent the downloading or acquisition of new images.

    Product
    Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1496-2017·2017-03-29

    Merge Cardio software recall due to patient data display error

    Merge Healthcare is recalling Merge Cardio software versions with IPID because the system may display images from different patients as if they belong to the same individual.

    Product
    Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1517-2017·2017-03-29

    Merge Healthcare Recalls Merge Cardio Software Due to Data Integrity Issues

    Merge Healthcare is recalling Merge Cardio software versions 9.0 through 9.0.8 because users can merge device files with confirmed reports, potentially adding unverified information.

    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
  • HighFDA (Devices)·Z-1498-2017·2017-03-29

    Merge Eye Station Import Utility Recalled for System Lockup Risk

    Merge Healthcare is recalling the Eye Station Import Utility software because system lockups may cause patient injury or delay diagnosis.

    Product
    Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1415-2017·2017-03-29

    Merge Cardio Software Recall Due to Missing Read-Only Notification

    Merge Healthcare is recalling Merge Cardio software versions 9.0.9 and earlier because a defect allows two physicians to access the same study report without a read-only prompt.

    Product
    Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1486-2017·2017-03-29

    Merge Healthcare Recalls Cardio Software Due to STAT Study Display Issue

    Merge Healthcare is recalling Merge Cardio software versions 9.0 through 10.1.2 because the study list fails to display STAT studies without a manual refresh.

    Product
    Merge Cardio software.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1470-2017·2017-03-22

    Merge Healthcare iConnect Enterprise Archive Software Recall for Routing Errors

    Merge Healthcare is recalling iConnect Enterprise Archive software versions 5.30.0 through 9.4.3 and V11.0 because routing exceptions may delay diagnosis or treatment.

    Product
    iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1457-2017·2017-03-22

    Merge Hemo software recalled due to study tab locking issue

    Merge Healthcare is recalling Merge Hemo software versions 6.10 through 9.40.3 because the system may incorrectly lock study tabs, potentially preventing access to data.

    Product
    Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1403-2017·2017-03-15

    Merge Cardio software recalled for incorrect measurement units in reports

    Merge Healthcare is recalling Merge Cardio software versions 9.0 and 10.0 because measurements from images or US carts do not transfer to reports in the correct unit of measure.

    Product
    Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1426-2017·2017-03-15

    Merge Unity PACS Software Recalled for Missing Demographic Data

    Merge Healthcare is recalling Unity PACS software version 11.0 because reports faxed to referring physicians were missing demographic header information.

    Product
    DR Systems Unity PACS software, now known as Merge Unity PACS
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1431-2017·2017-03-15

    Merge PACS Software Recalled for Telmed Protocol Data Propagation Failures

    Merge Healthcare is recalling specific versions of Merge PACS software because studies may fail to propagate or import via the telmed protocol.

    Product
    Merge PACS software. The firm name on the label is Merge Healthcare.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1385-2017·2017-03-08

    Merge Healthcare Recalls Unity PACS Software Due to Image Error

    Merge Healthcare is recalling Unity PACS software versions 11.0 and 11.0.1 because the software fails to add the correct tomo image.

    Product
    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, and media interchange of medical images from a variety
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1246-2017·2017-03-01

    Merge Eye Station Import Utility Recalled for Image Import Errors

    Merge Healthcare is recalling the Eye Station Import Utility because images were not importing properly and were imported under "unknown" due to a validation issue.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide