Recall Z-1775-2021 ยท LLZ System, Image Processing, Radiological
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
| Date | Apr 30, 2021 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Software design |
| Action | 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. Unt |
| Quantity | 44 US and 4 OUS |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Canada, Bermuda, Israel, Hadassah Medical Center. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151859 | Synapse Cardiovascular Fujifilm Medical Systems U.S.A, Inc., Aug 12, 2015 |