FDA Medical Device Recalls (openFDA)
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 number
- Z-1775-2021
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Product
- Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
- Status
- Terminated
- Initiated
- 2021-04-30
- Posted
- not on file
- Terminated
- 2024-07-29
- 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. 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.
- Quantity
- 44 US and 4 OUS
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Bermuda, Israel, Hadassah Medical Center.
- Lot, serial or model codes
- Software Versions: 6.0 to 6.2.1
- 510(k) numbers
- ["K151859"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 1000513161
- Firm city
- Lexington
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28