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Terminated

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.

FDA Recall Z-0068-2015 · Posted 2014-10-15

Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2014-08-28
Date Terminated2017-06-01
Product Quantity2,630

Reason for Recall

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.

Firm 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

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020995EFILM WORKSTATION WITH MODULESEfilm Medical, Inc. · 2002-04-12K012211EFILM WORKSTATIONEfilm Medical, Inc. · 2001-07-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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