Merge Healthcare, Inc.
Summary
- Total Recalls
- 93
- 510(k) Clearances
- 0
- Inspections
- 8
- Compliance Actions
- 1
Known Names
merge healthcare, merge healthcare incorporated
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2518-2025 | Class II | Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Produc | August 11, 2025 |
| Z-1400-2025 | Class II | VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2, 11.0.3, 11.0.4, | February 19, 2025 |
| Z-1399-2025 | Class II | VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, | February 19, 2025 |
| Z-1401-2025 | Class II | VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VER | February 19, 2025 |
| Z-1402-2025 | Class II | Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1 | February 19, 2025 |
| Z-1398-2025 | Class II | VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS | February 19, 2025 |
| Z-2387-2021 | Class II | Merge Hemo, Software packages 10.2, 10.3, and 10.4 | July 23, 2021 |
| Z-2944-2020 | Class II | Merge PACS | August 6, 2020 |
| Z-2403-2020 | Class II | Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Worksta | May 8, 2020 |
| Z-2063-2019 | Class II | Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1 | July 11, 2019 |
| Z-2062-2019 | Class II | Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1 | July 11, 2019 |
| Z-0939-2019 | Class II | The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging S | December 20, 2018 |
| Z-3105-2017 | Class II | Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label | August 14, 2017 |
| Z-2566-2018 | Class II | Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label | August 7, 2017 |
| Z-2754-2017 | Class II | Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, manageme | June 13, 2017 |
| Z-2601-2017 | Class II | Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI. | May 24, 2017 |
| Z-2620-2017 | Class II | Merge OrthoPACS software. | May 24, 2017 |
| Z-2591-2017 | Class II | Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed | May 8, 2017 |
| Z-2590-2017 | Class II | Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. | May 8, 2017 |
| Z-0350-2018 | Class II | Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - | April 6, 2017 |