Recall Z-0726-2017 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.
| Date | Mar 28, 2016 |
| Status | Terminated |
| Reason | Cut lines on the image may present horizontally rather than vertically. |
| Root cause | Component design/selection |
| Action | MERGE sent an Urgent Medical Device Recall dated March 28, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Merge Healthcare is working on correcting the issues and will inform customers once a fix is made available. Customers were asked to reply using the enclosed form and the return addressed envelope. If customers have further distributed the affected product they need to identify their customers and notify them at once of the product recall. Customers with questions were instructed to send an email to recall@ |
| Quantity | 537 sites potentially have the affected versions |
| Distribution | Worldwide Distribution - US (nationwide) Canada and foreign distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082144 | AMICAS PACS, VERSION 6.0 Amicas, Inc., Sep 5, 2008 |