Recall Z-2301-2016 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
| Date | Jan 30, 2016 |
| Status | Terminated |
| Reason | Studies coming over via telmed were missing patient's DOB, procedure, and referring physician. |
| Root cause | Software design |
| Action | The recalling firm issued Urgent: Medical Device Recall letters dated 1/27/2016 and 5/26/2016. The letter informed the customer of the affected product, the nature of the issue, the potential harm involved, and actions to be taken. The firm released a fix for the issue; and, customers were asked to complete and return the enclosed form by June 17, 2016. Questions can be directed to recall@merge.com. |
| Quantity | 109 sites have the affected versions |
| Distribution | Worldwide Distribution -- USA, New Zealand, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082144 | AMICAS PACS, VERSION 6.0 Amicas, Inc., Sep 5, 2008 |