Hartland, WI, United States
Merge Healthcare, Inc. recalls
12 recalls recorded since 2018, most recently on 22 July 2026. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls12
Ongoing (FDA)4
Terminated or completed8
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 22 July 2026
- Reason
- Software issue may cause measurements to be displayed inaccurately.
- Distribution
- US Nationwide distribution in the states of California, Florida, Kentucky, Nebraska, Washington.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3004-2026
- Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Ongoing Class II Medical devices
- Recall started
- 30 June 2026
- Reason
- Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, and UK.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2874-2026, Z-2875-2026
- Merge PACS, medical imaging diagnostic workstation
- Merge OrthoPACS, medical imaging diagnostic workstation
Ongoing Class II Medical devices
- Recall started
- 11 August 2025
- Reason
- 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 high-pressure range (>240 mmHg). The ARGUS PB-3000 is a vital signs monitoring instrument intended to be integrated into the Merge Hemo System. No other components of the Merge Hemo System are affected.
- Distribution
- US Nationwide distribution including in the states of Arizona, Arkansas, California, Florida, Louisiana, Mississippi, North Carolina, North Dakota, Oklahoma, Pennsylvania, Georgia, Illinois, Kentucky, Tennessee, Texas, Washington, and Wisconsin.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2518-2025
- 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, d
Ongoing Class II Medical devices
- Recall started
- 19 February 2025
- Reason
- 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.
- Distribution
- US
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1398-2025, Z-1399-2025, Z-1402-2025, Z-1401-2025, Z-1400-2025
- 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.
- 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 archivin
- 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 i
- 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.
- 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 comm
Terminated Class II Medical devices
- Recall started
- 23 July 2021
- Terminated
- 29 August 2023
- Reason
- 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.
- Distribution
- US distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2387-2021
- Merge Hemo, Software packages 10.2, 10.3, and 10.4
Terminated Class II Medical devices
- Recall started
- 6 August 2020
- Terminated
- 30 November 2022
- Reason
- Measurements done on the Merge PACS generated MPR s may have incorrect measurements.
- Distribution
- Domestic Distribution: IL, MO, NY, ND, MI, TX, FL, OH, UT, NE, MS, MN, DE, AR, CA, WI, MD, NC, NH, GA, VA, SC, PE, CT, NM, IN. International Distribution: CA, BE, UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2944-2020
Terminated Class II Medical devices
- Recall started
- 8 May 2020
- Terminated
- 23 June 2023
- Reason
- 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.
- Distribution
- US Nationwide distribution including in the states of IL, TX, OR, AZ, OH, TN, CA, UT, MO, GA, NM, OK, VA, IN, CT, and VT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2403-2020
- 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
Terminated Class II Medical devices
- Recall started
- 11 July 2019
- Terminated
- 17 March 2023
- Reason
- 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 (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).
- Distribution
- Nationwide distribution to Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South C
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2063-2019, Z-2062-2019
- Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1
- Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Terminated Class II Medical devices
- Recall started
- 20 December 2018
- Terminated
- 28 February 2023
- Reason
- 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).
- Distribution
- Distribution nationwide to Alabama, Alaska, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, , Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebras
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0939-2019
- 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 specific
Terminated Class II Medical devices
- Recall started
- 7 August 2017
- Terminated
- 18 May 2020
- Reason
- The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
- Distribution
- Nationwide distribution to CA, KY, ME, OH, OR, TN, TX, WA, WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2566-2018
- 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
Terminated Class II Medical devices
- Recall started
- 6 April 2017
- Terminated
- 10 July 2019
- Reason
- 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.
- Distribution
- Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0350-2018
- 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.
Terminated Class II Medical devices
- Recall started
- 23 January 2017
- Terminated
- 1 May 2021
- Reason
- 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.
- Distribution
- Domestic Distribution Only: Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Oklahoma, Tennessee, Texas.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0289-2021
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.