Merge Healthcare recalls
Merge Healthcare appears in 96 official U.S. recall notices indexed by RecallRadar, most recently on 2026-09-02.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
FDA Device · Class II · 2026-09-02 · Merge Healthcare - Merge PACS, medical imaging diagnostic workstation
FDA Device · Class II · 2026-08-12 · Merge Healthcare - Merge OrthoPACS, medical imaging diagnostic workstation
FDA Device · Class II · 2026-08-12 · Merge Healthcare - Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCS…
FDA Device · Class II · 2025-09-10 · Merge Healthcare - 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
FDA Device · Class II · 2025-03-26 · Merge Healthcare - 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
FDA Device · Class II · 2025-03-26 · Merge Healthcare - VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1
FDA Device · Class II · 2025-03-26 · Merge Healthcare - VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2
FDA Device · Class II · 2025-03-26 · Merge Healthcare - VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8
FDA Device · Class II · 2025-03-26 · Merge Healthcare - Merge Hemo, Software packages 10.2, 10.3, and 10.4
FDA Device · Class II · 2021-09-08 · Merge Healthcare - Merge LIS
FDA Device · Class II · 2020-11-04 · Merge Healthcare - Merge PACS
FDA Device · Class II · 2020-09-16 · Merge Healthcare - Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage:…
FDA Device · Class II · 2020-07-01 · Merge Healthcare - Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1
FDA Device · Class II · 2019-07-31 · Merge Healthcare - Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1
FDA Device · Class II · 2019-07-31 · Merge Healthcare - The WinStation Retinal Imager, also known as Merge Eye Station
FDA Device · Class II · 2019-03-06 · Merge Healthcare - Merge Unity software, formerly known as DR Systems Unity PACS software
FDA Device · Class II · 2018-08-08 · Merge Healthcare - Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number 13-00106-00) are two compon…
FDA Device · Class II · 2018-01-24 · Merge Healthcare - Merge Unity software, formerly known as DR Systems Unity PACS software
FDA Device · Class II · 2017-09-13 · Merge Healthcare - Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration o…
FDA Device · Class II · 2017-07-26 · Merge Healthcare - The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software
FDA Device · Class II · 2017-07-19 · Merge Healthcare - Merge LIS software
FDA Device · Class II · 2017-07-05 · Merge Healthcare - Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hemodynamics monitors, measures, and records ph…
FDA Device · Class II · 2017-07-05 · Merge Healthcare - SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and…
FDA Device · Class II · 2017-07-05 · Merge Healthcare - MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076), Product Usage:…
FDA Device · Class II · 2017-07-05 · Merge Healthcare - MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part Number: HW-HEMO-00075), Product Usage: Merge Hemodynamics moni…
FDA Device · Class II · 2017-07-05 · Merge Healthcare - Merge OrthoPACS software
FDA Device · Class II · 2017-06-28 · Merge Healthcare - Merge OrthoPACS software
FDA Device · Class II · 2017-06-28 · Merge Healthcare - Merge PACS software
FDA Device · Class II · 2017-06-21 · Merge Healthcare - Merge PACS software
FDA Device · Class II · 2017-06-21 · Merge Healthcare - Merge Cardio software
FDA Device · Class II · 2017-05-31 · Merge Healthcare - Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001
FDA Device · Class II · 2017-05-10 · Merge Healthcare - Merge Eye Station and Merge Eye Care PACS
FDA Device · Class II · 2017-04-26 · Merge Healthcare - Merge Hemo software
FDA Device · Class II · 2017-04-19 · Merge Healthcare - iConnect Enterprise Archive (ICEA) software
FDA Device · Class II · 2017-04-19 · Merge Healthcare - iConnect Enterprise Archive software
FDA Device · Class II · 2017-04-05 · Merge Healthcare - Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU)
FDA Device · Class II · 2017-04-05 · Merge Healthcare - iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and co…
FDA Device · Class II · 2017-04-05 · Merge Healthcare - Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI
FDA Device · Class II · 2017-03-29 · Merge Healthcare - Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI
FDA Device · Class II · 2017-03-29 · Merge Healthcare - Merge Cardio software
FDA Device · Class II · 2017-03-29 · Merge Healthcare - Merge Cardio software
FDA Device · Class II · 2017-03-29 · Merge Healthcare - Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare
FDA Device · Class II · 2017-03-29 · Merge Healthcare - Merge Hemo software
FDA Device · Class II · 2017-03-22 · Merge Healthcare - iConnect Enterprise Archive when used with RadSuite
FDA Device · Class II · 2017-03-22 · Merge Healthcare - DR Systems Unity PACS software, now known as Merge Unity PACS
FDA Device · Class II · 2017-03-15 · Merge Healthcare - Merge Cardio software
FDA Device · Class II · 2017-03-15 · Merge Healthcare - Merge PACS software
FDA Device · Class II · 2017-03-15 · Merge Healthcare - DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information managemen…
FDA Device · Class II · 2017-03-08 · Merge Healthcare - 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 He…
FDA Device · Class II · 2017-03-01 · Merge Healthcare