Recall Z-0068-2015 ยท LLZ System, Image Processing, Radiological
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
| Date | Oct 15, 2014 (initiated Aug 28, 2014) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |