Z-1775-2021Class II

Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a...

Name: Z-1775-2021 Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a...
Creator: Fujifilm Medical Systems U.S.A., Inc.
Published: 2021-04-30
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2021-04-30 / Terminated / root cause: software

FDA source

Fujifilm Medical Systems U.S.A., Inc. began a recall of Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system on 2021-04-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1775-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-30
Posted: 2021-06-02
Terminated: 2024-07-29
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
Product code: LLZ System, Image Processing, Radiological
Reason for recall: 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 tag: software
FDA 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 [email protected], if you have any further questions regarding this field action.
Quantity in commerce: 44 US and 4 OUS
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Canada, Bermuda, Israel, Hadassah Medical Center.
Product codes and lots: Software Versions: 6.0 to 6.2.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1775-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1775-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-02

Product code LLZ

K151859Class IISynapse CardiovascularFujifilm Medical Systems U.S.A, Inc. / cleared 2015-08-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)