Z-0707-2017Class II

Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used...

Name: Z-0707-2017 Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used...
Creator: Merge Healthcare, Inc.
Published: 2016-10-20
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2016-10-20 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation... on 2016-10-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0707-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-20
Posted: 2016-12-05
Terminated: 2019-05-30
Recalling firm: Merge Healthcare Incorporated
Product: 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 code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA root cause: Software design
Action: Merge Healthcare sent an Urgent Medical Device Recall letter dated October 12, 2016, to all affected consignees. The letter described the Product, Issue, Potential Harm, Containment by the Customer / User, Actions by Merge, and Actions by Customers. Advised consignees to discontinue using the product, and identify & notify all customers. Requested consignees for a response to the notification. Customers with questions were instructed to send an email to [email protected].
Quantity in commerce: 2163
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0707-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0707-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-05

Product code LLZ

K020995Class IIEfilm Workstation with ModulesEfilm Medical, Inc. / cleared 2002-04-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)