Recall Z-2379-2016 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
| Date | Jan 30, 2016 |
| Status | Terminated |
| Reason | The patient name in the Halo title bar and the thumbnails do not match the name on displayed images. |
| Root cause | Software design |
| Action | The recalling firm issued a letter dated 1/27/2016 via e-mail on 1/30/2016 explaining the reason for recall and instructing the customer to provide a copy of the notification to all users. A second letter was issued to nonresponders dated 5/25/2016 |
| Quantity | 93 sites have the affected version |
| Distribution | The software was distributed to medical facilities nationwide. Government distribution was made to MN. Foreign distribution was made to Australia and to the United Kingdom. There was no military 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 |