Recall Z-2471-2020 ยท LLZ System, Image Processing, Radiological
Fujifilm Medical Systems U.S.A., Inc.
Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server)
| Date | May 22, 2020 |
| Status | Open, Classified |
| Reason | Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In addition, the slice location of the image and/or the slice direction could be incorrect as well, and result in misdiagnosis |
| Root cause | Software design |
| Action | Fujifilm issued URGENT: Medical Device Correction and Removal notification via FedEx standard overnight mail on May 22, 2020, stating reason for recall, health risk and action to take: recommending that you do not perform Tomosynthesis on these views until the correction is applied. FUJIFILM is providing hotfixes for Synapse PACS Versions 5.5, 5.7.0, and 5.7.1 to resolve these issues. Please contact Customer Service at 1-888-FUJIMED (1-888-385-4633). Cmplete and return the Field Action Verification Form Providing the response with the information requested is essential for ensuring appropr |
| Quantity | 135 units |
| Distribution | Nationwide |
| 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 |