Z-0932-03

Synapse Version 2.2.1 and 2.3.1 software

Name: Z-0932-03 Synapse Version 2.2.1 and 2.3.1 software
Creator: Fujifilm Medical System USA, Inc.
Published: 2003-05-12
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2003-05-12 / Terminated / root cause: software

FDA source

Fujifilm Medical System USA, Inc. began a recall of Synapse Version 2.2.1 and 2.3.1 software on 2003-05-12. The reason FDA records is "Synapse Version 2.2.1 and 2.3.1 Software [Free-Hand Region] may lead to incorrect density calculations during CT scan". 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-0932-03
Status: Terminated
Initiated: 2003-05-12
Posted: 2003-06-12
Terminated: 2004-05-25
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Synapse Version 2.2.1 and 2.3.1 software
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Synapse Version 2.2.1 and 2.3.1 Software [Free-Hand Region] may lead to incorrect density calculations during CT scan
Root cause tag: software
FDA root cause: Other
Action: FujiFilm notified users via letter notification during the week of May 12, 2003. Users wll be visited by a Regional Service Engineer to install the corrected software.
Quantity in commerce: 54 units
Distribution: Nationwide Foreign: Canada, Germany, Israel, Japan
Product codes and lots: Verson 2.2.1 and 2.3.1.

Product code LLZ

K991257Class IIFuji Wavelet Compression or Ffcomp Irreversible CompressionFujifilm Medical System U.S.A., Inc. / cleared 1999-06-25

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)