Merge Healthcare, Inc.: eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that is used for viewing medical images. eFilm Workstation 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). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. In addition, eFilm Workstation can be integrated with an institution s existing HIS or RIS for a fully integrated electronic patient record.

Recall number

Z-0068-2015

Recalling firm

Merge Healthcare, Inc.

Product

eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that is used for viewing medical images. eFilm Workstation 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). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. In addition, eFilm Workstation can be integrated with an institution s existing HIS or RIS for a fully integrated electronic patient record.

Status

Terminated

Initiated

2014-08-28

Posted

2014-10-15

Terminated

2017-06-01

Reason

There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studies open and utilizing the thumbnail panel to select multiple series from multiple studies may lead to the selection of an incorrect study.

Root cause

Device Design

Action

Merge sent an Important Product Information Notice letter, dated August 22, 2014 to consignees. The letter stated the issue, identified affected product, provided instructions, and told of a product update expected to be available by September 15, 2014. Customers with questions should contact Customer Service at 877-741-5369

Quantity

2,630

Distribution

Worldwide Distribution - US Nationwide and the countries of : Argentina, Australia, Canada, Chile, France, Germany, Hungary, Iceland, Italy, Lithuania, Mexico, New Zealand, Romania, Russia, South Africa, Sweden, and Yemen.

Lot, serial or model codes

versions 4.0 and 4.0.1

510(k) numbers

["K012211","K020995"]

PMA numbers

not on file

Product code

LLZ

Firm FEI

1000116130

Firm city

Hartland

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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