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.

1–25 of 96

  • HighFDA (Devices)·Z-3004-2026·2026-09-02

    Merge Healthcare Recalls PACS Workstations Due to Inaccurate Measurements

    Merge Healthcare is recalling 20 Merge PACS and Merge OrthoPACS workstations because a software issue may cause measurements to be displayed inaccurately.

    Product
    Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2875-2026·2026-08-12

    Merge OrthoPACS Imaging Workstation Recall for Patient Data Display Issue

    Merge Healthcare is recalling 5 units of its Merge OrthoPACS medical imaging diagnostic workstation due to a software issue where thumbnails from a previously opened patient study may appear while a different patient study is currently open.

    Product
    Merge OrthoPACS, medical imaging diagnostic workstation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2874-2026·2026-08-12

    Merge PACS Medical Imaging Workstation Recalled Due to Patient Data Display Error

    Merge Healthcare is recalling 53 Merge PACS medical imaging workstations due to a software issue where thumbnails from one patient's study may incorrectly display when viewing a different patient's study, potentially compromising patient confidentiality.

    Product
    Merge PACS, medical imaging diagnostic workstation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2518-2025·2025-09-10

    Hemodynamic recording systems recalled over pressure sensor error during blood pressure measurement

    Merge Hemo systems are recalled because certain Schiller ARGUS PB-3000 patient data modules trigger a Pressure Sensor Defective error during non-invasive blood pressure measurement above 240 mmHg. 84 units are affected.

    Product
    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, displays, records and stores various physiologic and blood fl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1402-2025·2025-03-26

    Merge Cardio Software Recalled: Measurement Inconsistency in Patient Reports

    Merge Healthcare recalls Merge Cardio cardiovascular software due to measurement data inconsistency. When users manually edit or remeasure values in certain workflows, derived measurements may not match original measurements in patient reports.

    Product
    Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1398-2025·2025-03-26

    VERICIS Merge Cardio Cardiovascular System Software Recall for Measurement Inconsistency

    Merge Healthcare's VERICIS Merge Cardio software (versions 9.0.6 and 9.0.8) may produce measurement inconsistencies under specific workflows. Derived measurements may not match primitive measurements in final patient reports.

    Product
    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.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1400-2025·2025-03-26

    VERICIS Merge Cardio Medical Device Software Measurement Data Consistency Issue

    VERICIS Merge Cardio cardiovascular imaging software may display measurement values in patient reports that do not match original measurements when measurements are remeasured or manually edited. This affects 66 units distributed in the United States.

    Product
    VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1399-2025·2025-03-26

    VERICIS Merge Cardio may display inconsistent measurement data in clinical reports

    The VERICIS Merge Cardio system may display inconsistent cardiovascular measurements in patient reports when specific workflows are used. This could affect clinical decisions based on the reported data.

    Product
    VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1401-2025·2025-03-26

    Cardiovascular Information System Measurement Inconsistency in Merge Cardio

    Merge Healthcare's VERICIS Merge Cardio cardiovascular information system may display inconsistent measurements under specific workflows involving ultrasound remeasurement or manual measurement editing. No illnesses have been reported.

    Product
    VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2387-2021·2021-09-08

    Merge Hemo Software Recall Due to HL7 Lab Interface Safety Issue

    Merge Healthcare recalls Merge Hemo software versions 10.2, 10.3, and 10.4. The safety issue affects versions 9.x and 10.x when used with HL7 lab interfaces. No illnesses or injuries reported.

    Product
    Merge Hemo, Software packages 10.2, 10.3, and 10.4
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2403-2020·2020-07-01

    Merge Healthcare Software Recall for Inaccurate Z-Score Calculations

    Merge Healthcare is recalling specific versions of Merge Cardio software due to a calculation error that may produce false negative Z-Scores.

    Product
    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 archive clinical information from Camtronics and other vendor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2062-2019·2019-07-31

    Merge PACS Software Recalled for Mammography Image Display Errors

    Merge Healthcare is recalling specific versions of Merge PACS software because mammography images may not display in the correct reverse chronological order.

    Product
    Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2063-2019·2019-07-31

    Merge OrthoPACS Software Recalled for Image Display Ordering Issues

    Merge Healthcare is recalling 73 units of Merge OrthoPACS software due to potential display errors in image ordering and scrolling.

    Product
    Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0939-2019·2019-03-06

    Merge Eye Station Retinal Imager Recalled for Electrical Safety Defects

    Merge Healthcare is recalling 1,252 WinStation Retinal Imagers because certain configurations may produce electrical output exceeding allowable medical device limits.

    Product
    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 used to produce color or black and white images of the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2566-2018·2018-08-08

    Merge Unity Software Recalled for Incorrect Breast Cancer Risk Calculations

    Merge Healthcare is recalling Merge Unity software versions 10.0.6 and 10.0.7 because the software fails to identify atypical hyperplasia, leading to incorrect Gail Risk calculations for breast cancer.

    Product
    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, selection, processing, printing, telecommunications, and m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0350-2018·2018-01-24

    Merge Healthcare Recalls Power Strips in Hemo System Due to Overheating

    Merge Healthcare is recalling 1,150 power strips sold with the Merge Hemo System because an input resistor can overheat and cause the unit to smoke.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3105-2017·2017-09-13

    Merge Unity Software Recall for Incorrect Gail Risk Calculations

    Merge Healthcare is recalling Merge Unity software versions 10.0 through 11.1.2 Patch 4 because the software fails to identify atypical hyperplasia, leading to incorrect Gail Risk calculations.

    Product
    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, selection, processing, printing, telecommunications, and m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2754-2017·2017-07-26

    Merge Eye Care PACS Viewer 5.2 Recalled for Incorrect Image Sorting

    Merge Healthcare is recalling 18 units of Merge Eye Care PACS Viewer 5.2 due to a software defect that may cause incorrect study indexing and image misidentification.

    Product
    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 solution using databases for patient demographics, server
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2707-2017·2017-07-19

    Merge Healthcare Recalls Schiller PB 1000 Patient Data Module

    Merge Healthcare is recalling 555 Schiller PB 1000 Patient Data Modules because the analog output may not accurately reflect the pressure waveform used for fractional flow reserve calculations.

    Product
    The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2628-2017·2017-07-05

    Merge Healthcare Recalls LIS Software Due to Potential Wrong Results Verification

    Merge Healthcare is recalling specific versions of its LIS software because wrong laboratory results could be inadvertently verified under certain conditions.

    Product
    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 laboratory test results are reported.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2640-2017·2017-07-05

    Merge Healthcare Recalls SpO2 Cables for Hemodynamics Monitors

    Merge Healthcare is recalling 219 SpO2 connecting cables for its Hemodynamics monitors because they may stop displaying patient SpO2 readings, causing a slight delay in patient care.

    Product
    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 catheterization procedure. The Monitoring System is for the monitoring
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2642-2017·2017-07-05

    Merge Healthcare Recalls Pediatric SpO2 Sensors for Display Failure

    Merge Healthcare is recalling four MasimoSET pediatric SpO2 sensors because cables may stop displaying patient data, causing slight delays in care.

    Product
    MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2641-2017·2017-07-05

    Merge Healthcare Recalls Masimo SPO2 Sensors for Display Failure

    Merge Healthcare is recalling Masimo SPO2 ear clip sensors because cables may stop displaying SpO2 readings, causing slight delays in patient care.

    Product
    Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), 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
    Category
    Medical Device
    Distribution
    Distributed nationwide