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Merge Healthcare, Inc.

35 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Merge PACS, medical imaging diagnostic workstation recall (Z-2874-2026)Merge Healthcare, Inc.2026-08-04
Merge OrthoPACS, medical imaging diagnostic workstation recall (Z-2875-2026)Merge Healthcare, Inc.2026-08-04
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1 recall (Z-2518-2025)Merge Healthcare, Inc.2025-09-04
VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0. recall (Z-1398-2025)Merge Healthcare, Inc.2025-03-20
VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1. recall (Z-1399-2025)Merge Healthcare, Inc.2025-03-20
VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2, 11.0. recall (Z-1400-2025)Merge Healthcare, Inc.2025-03-20
VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0. recall (Z-1401-2025)Merge Healthcare, Inc.2025-03-20
Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12 recall (Z-1402-2025)Merge Healthcare, Inc.2025-03-20
The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital recall (Z-0939-2019)Merge Healthcare, Inc.2019-02-25
Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on t recall (Z-3105-2017)Merge Healthcare, Inc.2017-08-18
Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, recall (Z-2754-2017)Merge Healthcare, Inc.2017-07-10
Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a recall (Z-2628-2017)Merge Healthcare, Inc.2017-05-25
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Inten recall (Z-2123-2017)Merge Healthcare, Inc.2017-05-22
Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The Phase recall (Z-1923-2017)Merge Healthcare, Inc.2017-05-02
Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merg recall (Z-1778-2017)Merge Healthcare, Inc.2017-04-11
iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Health recall (Z-1762-2017)Merge Healthcare, Inc.2017-04-05
Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merg recall (Z-1496-2017)Merge Healthcare, Inc.2017-03-20
Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Ey recall (Z-1681-2017)Merge Healthcare, Inc.2017-03-13
iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge H recall (Z-1470-2017)Merge Healthcare, Inc.2017-03-10
DR Systems Unity PACS software, now known as Merge Unity PACS recall (Z-1426-2017)Merge Healthcare, Inc.2017-03-09
Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartl recall (Z-1415-2017)Merge Healthcare, Inc.2017-03-08
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. recall (Z-1403-2017)Merge Healthcare, Inc.2017-03-03
DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity recall (Z-1385-2017)Merge Healthcare, Inc.2017-03-02
Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. recall (Z-1180-2017)Merge Healthcare, Inc.2017-02-09
Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI. recall (Z-0878-2017)Merge Healthcare, Inc.2016-12-21
Merge RadSuite software. Radiological image processing system. recall (Z-2715-2016)Merge Healthcare, Inc.2016-09-02
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image recall (Z-2709-2016)Merge Healthcare, Inc.2016-09-01
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. recall (Z-2627-2016)Merge Healthcare, Inc.2016-08-23
Merge HEMO software. recall (Z-2341-2016)Merge Healthcare, Inc.2016-08-04
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. recall (Z-2303-2016)Merge Healthcare, Inc.2016-07-29
Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI. recall (Z-2159-2016)Merge Healthcare, Inc.2016-07-11
Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. O recall (Z-2144-2016)Merge Healthcare, Inc.2016-07-08
Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN recall (Z-2347-2015)Merge Healthcare, Inc.2015-08-06
Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Pa recall (Z-0143-2015)Merge Healthcare, Inc.2014-10-28
eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Pic recall (Z-0068-2015)Merge Healthcare, Inc.2014-10-15

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