Recall Z-1385-2017 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.
| Date | Mar 2, 2017 (initiated Apr 8, 2016) |
| Status | Terminated |
| Reason | The software is not adding the correct tomo image. |
| Root cause | Software design |
| Action | Merge sent an Urgent Medical Device Recall dated July 11, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions send an email to recall@merge.com |
| Quantity | 28 sites potentially have the affected software |
| Distribution | US Nationwide Distribution in the states of AL CA, CO, FL, IL, MD, MN, MT, NV, NY, OR, PA SC, TN, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041935 | DR SYSTEMS PACS, RELEASE 6.1 Dr Systems, Inc., Aug 16, 2004 |