PlainRecalls

Merge Healthcare, Inc.

Compiled from official public sources by the editorial team.

93 recalls on record · Latest: Sep 10, 2025

Merge Healthcare, Inc. Recall Insight

Merge Healthcare, Inc. appears on 93 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.091% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Sep 10, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 43 entries, severity tagging shows 0 critical, 43 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 43 of 43 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (43). The date window on this page runs from Oct 22, 2014 to Feb 15, 2017.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Feb 15, 2017

Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.

FDA Devices Moderate Feb 1, 2017

Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure

FDA Devices Moderate Jan 25, 2017

Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical inf…

FDA Devices Moderate Jan 18, 2017

Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Sys…

FDA Devices Moderate Jan 11, 2017

DR Systems Unity PACS software, now known as Merge Unity PACS software.

FDA Devices Moderate Dec 28, 2016

Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.

FDA Devices Moderate Dec 21, 2016

Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information includin…

FDA Devices Moderate Dec 21, 2016

Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Cam…

FDA Devices Moderate Dec 14, 2016

Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storag…

FDA Devices Moderate Dec 14, 2016

Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Wor…

FDA Devices Moderate Dec 7, 2016

Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to…

FDA Devices Moderate Dec 7, 2016

Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization proced…

FDA Devices Moderate Nov 30, 2016

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…

FDA Devices Moderate Nov 23, 2016

iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.

FDA Devices Moderate Nov 23, 2016

Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communi…

FDA Devices Moderate Nov 23, 2016

Merge LIS software.

FDA Devices Moderate Oct 26, 2016

CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.

FDA Devices Moderate Oct 26, 2016

CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of m…

FDA Devices Moderate Oct 26, 2016

Fusion Workstation.; Indicated for the transmission and review of radiological images.

FDA Devices Moderate Sep 28, 2016

CADstream software. Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of m…

FDA Devices Moderate Sep 28, 2016

Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and com…

FDA Devices Moderate Sep 21, 2016

RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.

FDA Devices Moderate Sep 14, 2016

Merge RadSuite software. Radiological image processing system.

FDA Devices Moderate Sep 7, 2016

iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. iConnect Enterprise Archive is intended for use as a v…

FDA Devices Moderate Sep 7, 2016

Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.

FDA Devices Moderate Sep 7, 2016

RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diag…

FDA Devices Moderate Aug 31, 2016

RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.

FDA Devices Moderate Aug 24, 2016

iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of pa…

FDA Devices Moderate Aug 24, 2016

iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of pa…

FDA Devices Moderate Aug 24, 2016

Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, se…

FDA Devices Moderate Aug 17, 2016

Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three…

FDA Devices Moderate Aug 17, 2016

Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.

FDA Devices Moderate Aug 10, 2016

Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dime…

FDA Devices Moderate Aug 10, 2016

Merge HEMO software.

FDA Devices Moderate Aug 10, 2016

Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and displ…

FDA Devices Moderate Jul 20, 2016

Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. OfficePACS is intended for the manipulation and displaying…

FDA Devices Moderate Jul 20, 2016

Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.

FDA Devices Moderate Feb 17, 2016

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, …

FDA Devices Moderate Jan 6, 2016

Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data fr…

FDA Devices Moderate Jan 6, 2016

Merge Cardio with software version 10.1 LA.

FDA Devices Moderate Aug 12, 2015

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…

FDA Devices Moderate Nov 5, 2014

Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo M…

FDA Devices Moderate Oct 22, 2014

eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Us…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Merge Healthcare, Inc. with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.