Fujifilm Medical Systems U.S.A., Inc. Recall 86532
Description: Synapse PACS Software Versions 5.1 and higher
Fujifilm Medical Systems U.S.A., Inc. Recall 86532 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0878-2021 |
| Event ID | 86532 |
| Event Description | Synapse PACS Software Versions 5.1 and higher |
| Product Type | Devices |
| Distribution | Software was distributed to medical facilities nationwide throughout the U.S. |
| Quantity | 235 |
| Recall 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. |
| Device Classification | 20210127 |
| Device Code Info | Software Versions 5.1, 5.2, 5.3, 5.4, 5.5, and 5.7. |
| Center Classification Date | 20210116 |
| Recall Initiation Date | 20200911 |
| Recalling Firm | Fujifilm Medical Systems U.S.A., Inc. |
| Initial Notification | Letter |
| Similar To |