Z-2043-2016Class II

Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm...

Name: Z-2043-2016 Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm...
Creator: Fujifilm Medical Systems U.S.A., Inc.
Published: 2016-05-10
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2016-05-10 / Terminated / root cause: software

FDA source

Fujifilm Medical Systems U.S.A., Inc. began a recall of Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm... on 2016-05-10. FDA classified it as Class II and gives the reason as "Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead". 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-2043-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-10
Posted: 2016-06-21
Terminated: 2019-02-20
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm Synapse PACS software version 4.4.010 and Fujifilm Synapse PACS software version 4.4.020 FUJIFILM Synapse Workstation Software (a Picture Archiving And Communications System) is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. Also intended for installation on an off-the-shelf PC networked with Fuji Synapse PACS.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Synapse cannot display image files, DICOM SR files, and/or Annotation files. The "Image Not Loaded" message displays instead
Root cause tag: software
FDA root cause: Software design
Action: The firm, FujiFilm, sent an "MEDICAL DEVICE CORRECTION" letter dated May 10, 2016 via Federal Express to its customers. The letter describes the product, problem and actions to be taken.The customers were instructed to: Extend the Ad hoc deletion retention period or discontinue use of Ad Hoc Deletion, and complete and submit the attached Customer Response Form to Fujifilm via fax to (203)-251-7863. Affected systems will be corrected via on-site visits by FMSU Customer Service Engineers upgrading to Version 4.4.100. Questions or concerns, contact the FUJI FILM Customer Support Center at 1- 888-FUJIMED Option #1 .
Quantity in commerce: 27 units
Distribution: US Distribution to states of: CA, FL, KS, NE, NY, and PA.
Product codes and lots: Software version: 4.4.000, 4.4.001, 4.4.004, 4.4.010, 4.4.020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2043-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2043-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-29	2016-06-21

Product code LLZ

K112439Class IISynapse Workstation Software Version 3.3.0Fujifilm Medical System U.S.A., Inc. / cleared 2011-10-17

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)