Merge Healthcare, Inc.
62 recalls on record · Latest: Sep 10, 2025
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