Recall Z-0878-2021 ยท LLZ System, Image Processing, Radiological
Fujifilm Medical Systems U.S.A., Inc.
Synapse PACS Software Versions 5.1 and higher
| Date | Sep 11, 2020 |
| Status | Open, Classified |
| Reason | There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality. |
| Root cause | Device Design |
| Action | Letter was sent to all affected customers on 09/11/2020 stating the following: There have been no reported patient injuries associated with these issues. In an effort to ensure the highest level of customer satisfaction, FUJIFILM will offer an upgrade to Synapse PACS 5.7.200US to resolve these issues. Until your upgrade is scheduled and completed, you can continue to safely use Synapse PACS by following these additional instructions: 1. When selecting a patient off the PowerJacket or work list, please ensure that the patient information displayed in the viewer matches the desired patient and |
| Quantity | 235 |
| Distribution | Software was distributed to medical facilities nationwide throughout the U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160108 | Synapse PACS Fujifilm Medical Systems U.S.A, Inc., Feb 3, 2016 |