Recall Z-2363-2016 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
| Date | Feb 5, 2016 |
| Status | Terminated |
| Reason | When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same. |
| Root cause | Software design |
| Action | The recalling firm's customer support notified customers via phone call beginning 2/5/2016 to inform them of the issue. Customers were informed that a software fix that corrects the issue was available. Customers were asked not to use the measurements on mammo images until upgraded. If customers want an upgrade, then someone would contact them to schedule the upgrade. |
| Quantity | 49 sites potentially have the affected versions |
| Distribution | Worldwide Distribution -- USA and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082144 | AMICAS PACS, VERSION 6.0 Amicas, Inc., Sep 5, 2008 |