Z-0918-2021Class II

FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 -

Name: Z-0918-2021 FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 -
Creator: Fujifilm Medical Systems U.S.A., Inc.
Published: 2020-12-11
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2020-12-11 / Terminated / root cause: software

FDA source

Fujifilm Medical Systems U.S.A., Inc. began a recall of FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or... on 2020-12-11. FDA classified it as Class II and gives the reason as "The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user". 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-0918-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-11
Posted: 2021-01-22
Terminated: 2021-11-17
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user.
Root cause tag: software
FDA root cause: Software change control
Action: On 12/11/2020 Fujifilm sent consignee notifications via FedEx Priority Overnight stating that there are issues with Synapse PACS Software Version 7.0.000 and 7.0.100. Fujifilm provided a work around until a hotfix is scheduled and completed.
Quantity in commerce: 1 unit
Distribution: US Nationwide distribution in the state of MD.
Product codes and lots: Versions 7.0.0 and 7.0.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0918-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0918-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-22

Product code LLZ

K190232Class IISynapse PACSFujifilm Corporation / cleared 2019-03-26

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)