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.

76–96 of 96

  • HighFDA (Devices)·Z-2709-2016·2016-09-07

    Merge Cardio software recall due to incorrect patient data saving

    Merge Healthcare is recalling Merge Cardio software versions 10.1 and 10.1.1 because reports may be saved to incorrect patient records.

    Product
    Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2685-2016·2016-09-07

    Merge Healthcare Recalls RadSuite Software Due to Image Display Errors

    Merge Healthcare is recalling RadSuite software versions 8.30.6 through 8.30.6.3 because interventional radiology images are not displaying correctly.

    Product
    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.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2686-2016·2016-09-07

    Merge Healthcare Recalls iConnect Enterprise Archive Due to Image Display Issues

    Merge Healthcare is recalling iConnect Enterprise Archive software because interventional radiology images are not displaying correctly in RadSuite.

    Product
    iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. 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
    2 states
  • HighFDA (Devices)·Z-2627-2016·2016-08-31

    Merge Healthcare Recalls RadSuite Software Due to Image Display Error

    Merge Healthcare is recalling RadSuite software versions 5.30 and 5.35 because the viewer may skip image slices when navigating with multiple viewports.

    Product
    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-2551-2016·2016-08-24

    Merge Unity Z3D Software Recalled for Calcium Score Inaccuracy

    Merge Healthcare is recalling Merge Unity Z3D software because it cannot accurately determine calcium scores for scans with slice thicknesses other than 3 mm.

    Product
    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 of medical images from a variety of diagnostic imaging sys
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2532-2016·2016-08-24

    Merge Healthcare Recalls iConnect Access Software Due to Patient Data Errors

    Merge Healthcare is recalling iConnect Access software because it may display incorrect patient demographics after edits, potentially affecting medical specialists.

    Product
    iConnect Access used with Ortho 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2531-2016·2016-08-24

    Merge Healthcare Recalls iConnect Access Software for Patient Data Errors

    Merge Healthcare is recalling iConnect Access software because it may display incorrect patient demographics for studies originating on Merge PACS or Ortho PACS.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2379-2016·2016-08-17

    Merge PACS software recalled due to patient name mismatch

    Merge Healthcare is recalling PACS software versions V6.0.2.0 MR2 and earlier because patient names in the interface do not match the displayed images.

    Product
    Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2363-2016·2016-08-17

    Merge PACS software recall for inconsistent mammography lesion measurements

    Merge Healthcare is recalling specific versions of Merge PACS software because lesion measurements differ between unmagnified and magnified mammography images.

    Product
    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.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2341-2016·2016-08-10

    Merge HEMO software recall for inaccurate INR display

    Merge Healthcare is recalling 37 units of Merge HEMO software because the displayed International Normalized Ratio (INR) value does not match the imported value.

    Product
    Merge HEMO software.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2303-2016·2016-08-10

    Merge PACS Software Recall for Annotation Display Defect

    Merge Healthcare is recalling Merge PACS 6.0 software because it fails to display annotations on certain loaded studies.

    Product
    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 digitally acquired images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2301-2016·2016-08-10

    Merge PACS software recall for missing patient data in telmed studies

    Merge Healthcare is recalling specific versions of Merge PACS software because studies received via telmed were missing patient DOB, procedure, and referring physician information.

    Product
    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.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2159-2016·2016-07-20

    Merge OfficePACS Software Recalled for Potential Data Loss

    Merge Healthcare is recalling OfficePACS software version 3.4 because archiving failures may cause data loss at 49 medical facilities.

    Product
    Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-2144-2016·2016-07-20

    Merge Healthcare Recalls OfficePACS Software Due to Data Loss Risk

    Merge Healthcare is recalling OfficePACS software versions 4.0 through 4.2 because a defect in the archiving function may cause potential data loss.

    Product
    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 professional. It can show images from different modalities and i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0794-2016·2016-02-17

    Merge Healthcare Recalls RadSuite Picture Archive System for Measurement Errors

    Merge Healthcare is recalling RadSuite picture archive systems because they may display incorrect Standardized Uptake Values (SUV). The recall covers 164 units distributed nationwide.

    Product
    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, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0554-2016·2016-01-06

    Merge Hemo Software Recalled Due to Incomplete Validation

    Merge Healthcare is recalling Merge Hemo software version 10.0 LA because it was distributed to three customers before being fully validated in-house.

    Product
    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.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0555-2016·2016-01-06

    Merge Healthcare Recalls Unvalidated Cardio and HEMO Software Versions

    Merge Healthcare is recalling Merge HEMO V10.0 and Merge CARDIO V10.1 software distributed to three customers before complete in-house validation.

    Product
    Merge Cardio with software version 10.1 LA.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2347-2015·2015-08-12

    Merge Hemo System Recalled for Freeze-Up During Cardiac Procedures

    Merge Healthcare is recalling 451 Merge Hemo systems used with Masimo PHASEIN modules due to system freeze-ups that required moving patients to other cath labs.

    Product
    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 data from a human patient undergoing a cardiac catheterizatio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0143-2015·2014-11-05

    Merge Hemo Diagnostic Computer Recalled for Stale Oxygen and Heart Rate Data

    Merge Healthcare is recalling 52 Hemo Programmable diagnostic computers because the SpO2 and heart rate values displayed may not update to reflect changes in the patient's condition.

    Product
    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 parameters and evaluations are registered and calculat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0068-2015·2014-10-22

    Merge Healthcare Recalls eFilm Workstation Software Due to Image Selection Error

    Merge Healthcare is recalling eFilm Workstation versions 4.0 and 4.0.1 because a software defect may cause users to select the wrong patient study when using the thumbnail panel.

    Product
    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 medical images. eFilm Workstation receives digital image
    Category
    Medical Device
    Distribution
    Distributed nationwide