Brand

Merge Healthcare, Inc. Recalls

59 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Merge Healthcare, Inc..

59Total Recalls
0Critical
13,805Units Affected
Aug 11, 2025Most Recent
All Recalls

Every Merge Healthcare, Inc. Recall

Sorted by most recent. Click any recall for full details.

59 recalls
High RiskFDA
Merge Healthcare, Inc.
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model ...
Cardiac Devices·84 affected·Aug 11, 2025
High RiskFDA
Merge Healthcare, Inc.
VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular info...
Medical Devices·2 affected·Feb 19, 2025
High RiskFDA
Merge Healthcare, Inc.
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 ...
Medical Devices·11 affected·Feb 19, 2025
High RiskFDA
Merge Healthcare, Inc.
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....
Medical Devices·253 affected·Feb 19, 2025
High RiskFDA
Merge Healthcare, Inc.
VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular ...
Medical Devices·37 affected·Feb 19, 2025
High RiskFDA
Merge Healthcare, Inc.
Merge Hemo, Software packages 10.2, 10.3, and 10.4
Medical Devices·326 affected·Jul 23, 2021
High RiskFDA
Merge Healthcare, Inc.
Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage...
Medical Devices·62 affected·May 8, 2020
High RiskFDA
Merge Healthcare, Inc.
Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Medical Devices·73 affected·Jul 11, 2019
High RiskFDA
Merge Healthcare, Inc.
Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Medical Devices·179 affected·Jul 11, 2019
High RiskFDA
Merge Healthcare, Inc.
Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. M...
Diagnostic Devices·98 affected·Aug 14, 2017
High RiskFDA
Merge Healthcare, Inc.
Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. M...
Diagnostic Devices·11 affected·Aug 7, 2017
High RiskFDA
Merge Healthcare, Inc.
Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integratio...
Medical Devices·18 affected·Jun 13, 2017
High RiskFDA
Merge Healthcare, Inc.
Merge OrthoPACS software.
Medical Devices·98 affected·May 24, 2017
High RiskFDA
Merge Healthcare, Inc.
Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication,...
Medical Devices·47 affected·May 8, 2017
High RiskFDA
Merge Healthcare, Inc.
Merge LIS
Medical Devices·47 affected·Jan 23, 2017
High RiskFDA
Merge Healthcare, Inc.
Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalm...
Medical Devices·182 affected·Dec 9, 2016
High RiskFDA
Merge Healthcare, Inc.
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 (I...
Diagnostic Devices·29 affected·Jul 14, 2016
High RiskFDA
Merge Healthcare, Inc.
iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·60 affected·May 25, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to be used to acquire, store, print, ...
Medical Devices·30 affected·Apr 13, 2016
High RiskFDA
Merge Healthcare, Inc.
DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information man...
Diagnostic Devices·28 affected·Apr 8, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
Medical Devices·1,627 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physio...
Cardiac Devices·24 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio software.
Medical Devices·217 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hemodynamics monitors, measures, and rec...
Cardiac Devices·2 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures...
Cardiac Devices·219 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
Medical Devices·333 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·17 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·29 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
Medical Devices·78 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare.
Medical Devices·248 affected·Apr 4, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterizati...
Cardiac Devices·242 affected·Mar 28, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy read...
Medical Devices·534 affected·Mar 28, 2016
High RiskFDA
Merge Healthcare, Inc.
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...
Medical Devices·1,627 affected·Mar 28, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communicatio...
Medical Devices·537 affected·Mar 28, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical informat...
Medical Devices·198 affected·Mar 28, 2016
High RiskFDA
Merge Healthcare, Inc.
The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
Medical Devices·555 affected·Mar 10, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
Medical Devices·116 affected·Feb 9, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimension...
Medical Devices·49 affected·Feb 5, 2016
High RiskFDA
Merge Healthcare, Inc.
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·25 affected·Jan 31, 2016
High RiskFDA
Merge Healthcare, Inc.
iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. iConnect Enterprise Archive is intended fo...
Medical Devices·96 affected·Jan 30, 2016
High RiskFDA
Merge Healthcare, Inc.
CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·844 affected·Jan 30, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate c...
Medical Devices·324 affected·Jan 30, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional an...
Medical Devices·109 affected·Jan 30, 2016
High RiskFDA
Merge Healthcare, Inc.
iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various...
Diagnostic Devices·146 affected·Jan 30, 2016
High RiskFDA
Merge Healthcare, Inc.
iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various...
Diagnostic Devices·146 affected·Jan 30, 2016
High RiskFDA
Merge Healthcare, Inc.
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...
Medical Devices·164 affected·Dec 17, 2015
High RiskFDA
Merge Healthcare, Inc.
Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·8 affected·Nov 17, 2015
High RiskFDA
Merge Healthcare, Inc.
Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiol...
Cardiac Devices·2 affected·Oct 26, 2015