Fujifilm Medical Systems U.S.A., Inc. Synapse PACS Software Versions 5.1 and higher Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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 matches the PowerJacket. 2. If using a Siemens Modality, Max SUVs should not be used when rendering a clinical decision until the issue is corrected. Please complete and return the Field Action Verification Form attached on page 3 of this communication. Providing the response with the information requested is essential for ensuring appropriate action is taken.