Fujifilm Medical Systems U.S.A., Inc. Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
Brand
Fujifilm Medical Systems U.S.A., Inc.
Lot Codes / Batch Numbers
Software Versions: 6.0 to 6.2.1
Products Sold
Software Versions: 6.0 to 6.2.1
Fujifilm Medical Systems U.S.A., Inc. is recalling Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular ima due to Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does not increase when a patient merge activity is executed in a specific sequence
Recommended Action
Per FDA guidance
Fujifilm issue consignee notifications via email on April 30, 2021. Letter states reason for recall, health risk and action to take: ACTIONS TO BE TAKEN BY CUSTOMER/END USER FUJIFILM will offer an upgrade to Synapse CV 6.2.2 to resolve this issue. FUJIFILM recommends the following actions: 1) 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. 2) Contact Customer Service at 1-888-FUJIMED (1-888-385-4633) to open a ticket for the upgrade. Until your upgrade is scheduled and completed, Advanced Reporting users can continue to safely use Synapse CV by choosing one of the following options: 1) Merge the older patient record to the newer patient record, and then delete the older patient record. This sequence retains the most recent internal patient database ID and deletes an older internal patient database ID that will not be erroneously reassigned. 2) Merge the newer patient record to the older patient record only after additional new patients have been added beyond the record you want to merge. This sequence ensures that the most recent internal patient database ID is assigned to a record that is not involved in the merge activity. 3) Always check patient information presented in the report with other information provided for that patient/study. Please contact our field action coordinator, Jeffrey Wan, via phone at 201-675-8947 or email at jeffrey.wan@fujifilm.com, if you have any further questions regarding this field action.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026