Recall Z-3105-2017 ยท LLZ System, Image Processing, Radiological
Merge Healthcare, Inc.
Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity 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 | Aug 18, 2017 (initiated Aug 14, 2017) |
| Status | Terminated |
| Reason | The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation. |
| Root cause | Process design |
| Action | MERGE sent a Medical Device Recall letter dated August 11, 2017, to all affected customers. Customers were advised to discontinue using the affected product and to reply using the enclosed form. Customers with questions were instructed to send an email to recall@merge.com. For questions regarding this recall call 262-912-3514. |
| Quantity | 98 sites have the potentially affected software |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |