PlainRecalls

Merge Healthcare, Inc.

62 recalls on record · Latest: Sep 10, 2025

Merge Healthcare, Inc. Recall Insight

Merge Healthcare, Inc. appears on 62 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.074% 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 50 entries, severity tagging shows 0 critical, 50 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 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 (50). The date window on this page runs from Sep 7, 2016 to Sep 10, 2025.

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 Sep 10, 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…

FDA Devices Moderate Mar 26, 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 syst…

FDA Devices Moderate Mar 26, 2025

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 integr…

FDA Devices Moderate Mar 26, 2025

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 Car…

FDA Devices Moderate Mar 26, 2025

VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information …

FDA Devices Moderate Sep 8, 2021

Merge Hemo, Software packages 10.2, 10.3, and 10.4

FDA Devices Moderate Nov 4, 2020

Merge LIS

FDA Devices Moderate Jul 1, 2020

Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is…

FDA Devices Moderate Jul 31, 2019

Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1

FDA Devices Moderate Jul 31, 2019

Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1

FDA Devices Moderate Aug 8, 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 i…

FDA Devices Moderate Sep 13, 2017

Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity i…

FDA Devices Moderate Jul 26, 2017

Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthal…

FDA Devices Moderate Jul 19, 2017

The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.

FDA Devices Moderate Jul 5, 2017

Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hemodynamics monitors, measures, and records physiol…

FDA Devices Moderate Jul 5, 2017

SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and record…

FDA Devices Moderate Jun 28, 2017

Merge OrthoPACS software.

FDA Devices Moderate Jun 21, 2017

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

FDA Devices Moderate May 31, 2017

Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, transfer, an…

FDA Devices Moderate May 10, 2017

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 …

FDA Devices Moderate Apr 19, 2017

Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data f…

FDA Devices Moderate Apr 19, 2017

iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.

FDA Devices Moderate Apr 5, 2017

Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).

FDA Devices Moderate Mar 29, 2017

Merge Cardio software.

FDA Devices Moderate Mar 29, 2017

Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.

FDA Devices Moderate Mar 29, 2017

Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.

FDA Devices Moderate Mar 29, 2017

Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.

FDA Devices Moderate Mar 29, 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 Mar 15, 2017

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

FDA Devices Moderate Mar 8, 2017

DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information management syst…

FDA Devices Moderate Mar 1, 2017

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,…

FDA Devices Moderate Feb 22, 2017

The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.

FDA Devices Moderate Feb 15, 2017

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

FDA Devices Moderate Feb 15, 2017

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

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 11, 2017

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

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 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 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 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 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…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

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