PlainRecalls

Merge Healthcare, Inc.

62 recalls on record · Latest: Sep 10, 2025

FDA Devices Moderate Sep 7, 2016

Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.

FDA Devices Moderate Aug 31, 2016

RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.

FDA Devices Moderate Aug 24, 2016

iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of pa…

FDA Devices Moderate Aug 24, 2016

iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of pa…

FDA Devices Moderate Aug 17, 2016

Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three…

FDA Devices Moderate Aug 17, 2016

Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.

FDA Devices Moderate Aug 10, 2016

Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dime…

FDA Devices Moderate Aug 10, 2016

Merge HEMO software.

FDA Devices Moderate Feb 17, 2016

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, 5.30.4 HF0418E, …

FDA Devices Moderate Jan 6, 2016

Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data fr…

FDA Devices Moderate Jan 6, 2016

Merge Cardio with software version 10.1 LA.

FDA Devices Moderate Oct 22, 2014

eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Us…