Recall Z-2992-2018 ยท DQK Computer, Diagnostic, Programmable
Hitachi Healthcare Americas Corp Informatics Division
VidiStar(TM) PACS & DICOM Viewer Software system
| Date | Aug 28, 2018 |
| Status | Terminated |
| Reason | The secure filesystem client software used in the interface between the Vidistar PACS and an EHR system may cause intermixed images from multiple patients showing in a single study. |
| Root cause | Software in the Use Environment |
| Action | The firm initiated the recall by email on 08/28/2018. The firm will be removing the 3rd party software from the interface and replacing it with new software and notify the affected customers when the action is completed. |
| Quantity | 12 units |
| Distribution | SC, CO, IL, AZ, MT, OH, IN, TX, GA, MA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083910 | VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWER Vidistar, LLC, Apr 15, 2009 |