Z-0282-2021Class II

Synapse PACS Software Version 5.6.1 -

Name: Z-0282-2021 Synapse PACS Software Version 5.6.1 -
Creator: Fujifilm Medical Systems U.S.A., Inc.
Published: 2020-09-11
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2020-09-11 / Terminated / root cause: software

FDA source

Fujifilm Medical Systems U.S.A., Inc. began a recall of Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum... on 2020-09-11. FDA classified it as Class II and gives the reason as "FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to 3D Sphere - other density tools are not affected". 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-0282-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-11
Posted: 2020-10-22
Terminated: 2021-11-17
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Synapse PACS Software Version 5.6.1 - 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: FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to 3D Sphere - other density tools are not affected.
Root cause tag: software
FDA root cause: Software change control
Action: Letter was sent to all affected customers on 09/11/2020 stating the following: FUJIFILM will offer an upgrade to Synapse PACS 7.1.100 to resolve this issue. Synapse PACS 7.1.100 is estimated to be available by the end of September. Until the patch is available, users can continue to safely use Synapse PACS by following these additional instructions: 1. Ensure that the 3D Sphere MAX value is within the spheres range. If the 3D Sphere MAX value is observed to be much higher than expected, the value should not be used when rendering a clinical decision until the issue is corrected. Customers should complete and return the Field Action Verification Form attached to the recall letter.
Quantity in commerce: 1
Distribution: US Nationwide distribution including in the state of Minnesota.
Product codes and lots: Synapse Software Version 5.6.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0282-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0282-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-28	2020-10-22

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)