Merge Healthcare, Inc.

Complete recall history across all FDA and CPSC categories — 93 total recalls

Merge Healthcare, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (93)

FDA medical device enforcement actions by Merge Healthcare, Inc.. Showing most recent 50.

Date Product Reason Class
Aug 11, 2025 Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions ... Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an i... Class II
Feb 19, 2025 VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: ... When following a specific less typical workflow in which the user remeasures ... Class II
Feb 19, 2025 VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: ... When following a specific less typical workflow in which the user remeasures ... Class II
Feb 19, 2025 Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.... When following a specific less typical workflow in which the user remeasures ... Class II
Feb 19, 2025 VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: ... When following a specific less typical workflow in which the user remeasures ... Class II
Feb 19, 2025 VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9... When following a specific less typical workflow in which the user remeasures ... Class II
Jul 23, 2021 Merge Hemo, Software packages 10.2, 10.3, and 10.4 The firm identified a safety issue affecting the software associated with Mer... Class II
Aug 6, 2020 Merge PACS Measurements done on the Merge PACS generated MPR s may have incorrect measur... Class II
May 8, 2020 Merge Healthcare Merge Application Server Software Release and Merge Healthca... An error in the calculation of the Michigan Reference Ranges can generate an ... Class II
Jul 11, 2019 Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1 Potential for prior thumbnails to not display in reverse chronological order ... Class II
Jul 11, 2019 Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1 Potential for prior thumbnails to not display in reverse chronological order ... Class II
Dec 20, 2018 The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DC... Certain configurations of Merge Eye Station hardware may result in electrical... Class II
Aug 14, 2017 Merge Unity software, formerly known as DR Systems Unity PACS software. The ... The software is not identifying the patient as having atypical hyperplasia, r... Class II
Aug 7, 2017 Merge Unity software, formerly known as DR Systems Unity PACS software. The ... The software is not identifying the patient as having atypical hyperplasia, r... Class II
Jun 13, 2017 Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution fo... When the user has not set up any user preference on the sorting order to rend... Class II
May 24, 2017 Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Ha... Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate v... Class II
May 24, 2017 Merge OrthoPACS software. A migrated study that has annotations will display the annotations, but when ... Class II
May 8, 2017 Merge PACS software. The firm name on the label is Merge Healthcare, Hartlan... Merge PACS did not show unviewed images when the last view was skipped. There... Class II
May 8, 2017 Merge PACS software. Merge PACS (Picture Archiving Communication System) is... When cut lines are shown on an image, the lines may go from being vertical an... Class II
Apr 6, 2017 Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power s... Merge is conducting a hardware recall (replacement) of Fellows "Mighty 8" Pow... Class II
Jan 23, 2017 Merge LIS A defect in the software resulted in medications that are not associated with... Class II
Dec 9, 2016 Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStat... This recall has been initiated due to an issue related to the potential accid... Class II
Dec 9, 2016 Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinSt... Merge received reports of Merge Eye Station being unable to capture images of... Class II
Oct 20, 2016 Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a... A product issues happens for RF projection images. If user measures on RF ima... Class II
Jul 14, 2016 Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30... It was reported by a customer that RadSuite images are not appearing as read... Class II
May 25, 2016 iConnect Access software. The firm name on the label is Merge Healthcare, Ha... Software displayed incorrect prior reports in the viewport area, only when mo... Class II
Apr 15, 2016 Merge LIS software. The firm name on the label is Merge Healthcare. Merge... There are potential issues with results reporting for certain run-based tests... Class II
Apr 13, 2016 Merge Cardio software. The firm name on the label is Merge Healthcare, Hartl... Fetal patient report was automatically pulling prior measurement data for a p... Class II
Apr 8, 2016 DR Systems Unity PACS software, now known as Merge Unity PACS Reports were missing demographic header information when they were faxed to r... Class II
Apr 8, 2016 DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usa... The software is not adding the correct tomo image. Class II
Apr 4, 2016 Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitor... In some instances, the system will lock tabs within a study, even when a seco... Class II
Apr 4, 2016 MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part ... Under certain conditions, the cables used with the Hemo system during a patie... Class II
Apr 4, 2016 iConnect Enterprise Archive software. The versions allow images to be stored without pixel data, resulting in the s... Class II
Apr 4, 2016 iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is ... The study is archived but cannot be opened in iConnect Access and cannot send... Class II
Apr 4, 2016 Merge Cardio software. The firm name on the label is Merge Healthcare, Hartla... When taking measurements from images on the Cardio workstation or from the US... Class II
Apr 4, 2016 MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger cli... Under certain conditions, the cables used with the Hemo system during a patie... Class II
Apr 4, 2016 iConnect Enterprise Archive when used with RadSuite. The firm name on the la... The software produced a number of "do not route" exceptions, which may resu... Class II
Apr 4, 2016 Merge Eye Station and Merge Eye Care PACS. During an antivirus program scan of the Eye Station or Eye Care PACS, the ant... Class II
Apr 4, 2016 Merge PACS software. The firm name on the label is Merge Healthcare. Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate v... Class II
Apr 4, 2016 Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Me... System locks up which may result in potential patient injury or delay in diag... Class II
Apr 4, 2016 Merge PACS software. The firm name on the label is Merge Healthcare, Hartlan... Potential exists for an incorrect patient image being displayed which could r... Class II
Apr 4, 2016 Merge Cardio software using EchoIMS. The firm name on the label is Merge Hea... A situation can occur allowing two physicians to access the same study report... Class II
Apr 4, 2016 iConnect Enterprise Archive (ICEA) software. The firm name on the labeling i... An error message can occur resulting in the prior studies being unavailable f... Class II
Apr 4, 2016 SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-0001... Under certain conditions, the cables used with the Hemo system during a patie... Class II
Apr 4, 2016 Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Pr... Under certain conditions, the cables used with the Hemo system during a patie... Class II
Apr 4, 2016 Merge Cardio software. Cardio study list does not show STAT studies without refreshing. Class II
Apr 4, 2016 Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hart... Use of the software may show an incorrect value to the user when viewing the ... Class II
Apr 4, 2016 Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS,... The system will completely stop allowing the downloading or acquisition of ne... Class II
Mar 28, 2016 Merge Cardio software. Product Usage: Merge Cardio is a system intended... If a reader selects Multi-study review prior to the original study completing... Class II
Mar 28, 2016 Merge Cardio software. Merge Cardio is a system intended to be used to ac... If images are sent without an order in the system, they will be matched with ... Class II

View all 93 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

Explore More Recalls

Search recalls by category, state, reason, or firm across all our databases.