Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0707-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). eFilm Workstation with Modules can be used to communicate, process and display medical images. Users have access to various image processing and measurement tools to assist them in viewing images. In addition, users can overlay templates on medical images to aid in preoperative planning. eFilm Workstation with Modules can be integrated with an institution s existing HIS or RIS for a fully integrated electronic patient record. Typical users of eFilm Workstation with Modules are trained medical professionals, including but not limited to radiologists, technologists and clinicians

Product Classification:

Class II

Date Initiated: October 20, 2016

Date Posted: December 14, 2016

Recall Number: Z-0707-2017

Event ID: 75270

Reason for Recall:

A product issues happens for RF projection images. If user measures on RF image, .cal (Calibration) is not displayed and measurement is not correct. The .cal label is not displayed on the projection images after calibration is performed which should be present if the measurement is presented based on Pixel Spacing.

Status: Terminated

Product Quantity: 2163

Code Information:

EFilm Workstation and eFilm Lite versions 2.1, 2.1.2, 3.0, 3.1, 3.3.5, 3.4, 4.0, 4.0.1, 4.0.2, 4.0.3 and 4.1.

Distribution Pattern:

Worldwide Distribution - US: Nationwide including DC, GU, PR and Internationally to Canada, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Congo, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Guatemala, hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mauritania, Mexico, Netherlands, New Caledonia, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Vietnam, and Yemen.

Voluntary or Mandated:

Voluntary: Firm initiated