eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communicati
FDA device recall Z-0068-2015 · posted 2014-10-15 · Terminated
Recall details
- Recalling firm
- Merge Healthcare, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 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 Afri
- Date initiated
- 2014-08-28
- Date posted
- 2014-10-15
- Date terminated
- 2017-06-01
- Location
- Hartland, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EFILM WORKSTATION WITH MODULES (K020995) | Efilm Medical, Inc. | 2002-04-12 |
| EFILM WORKSTATION (K012211) | Efilm Medical, Inc. | 2001-07-31 |