Z-0622-06

Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS

Name: Z-0622-06 Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS
Creator: Fujifilm Medical System USA, Inc.
Published: 2006-02-03
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2006-02-03 / Terminated

FDA source

Fujifilm Medical System USA, Inc. began a recall of Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS on 2006-02-03. The reason FDA records is "Image orientation and orientation markers may not match when an image is rotated or flipped when the CT Image is preset". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0622-06
Status: Terminated
Initiated: 2006-02-03
Posted: 2006-03-15
Terminated: 2012-03-16
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Image orientation and orientation markers may not match when an image is rotated or flipped when the CT Image is preset.
FDA root cause: Other
Action: FujiFilm Medical Systems USA notified users by letter dated 2/3/06. Users are requested to deactivate the CT Image Processing functionality SWAT (Synapse Web Administration Tool).
Quantity in commerce: 179 units
Distribution: Nationwide Foreign: Canada, Japan, Germany
Product codes and lots: Versions 3.1.0 and 3.1.1

Product code LLZ

K051553Class IIFuji Synapse Workstation SoftwareFujifilm Medical Systems U.S.A, Inc. / cleared 2005-07-07

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)