Z-1612-2015Class II

Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular...

Name: Z-1612-2015 Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular...
Creator: Fujifilm Medical Systems U.S.A., Inc.
Published: 2015-02-04
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2015-02-04 / Terminated / root cause: software

FDA source

Fujifilm Medical Systems U.S.A., Inc. began a recall of Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended Use: Picture Archiving and... on 2015-02-04. FDA classified it as Class II and gives the reason as "Under certain circumstances the patient Demographics in a report exported into the EMR may not match the demographics shown in the corresponding Synapse CV clinical report". 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-1612-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-04
Posted: 2015-05-14
Terminated: 2018-09-20
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended Use: Picture Archiving and Communication System Computer, Diagnostic, Programmable
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: Under certain circumstances the patient Demographics in a report exported into the EMR may not match the demographics shown in the corresponding Synapse CV clinical report.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: Fujifilm Medical on 2/4/14 , contacted users and advised to discontinue using HL7 reports pending FMSU determination of root cause. Firm issued follow-up letters on 2/24/14 and 7/24/14 advising users of a mandatory upgrade to version 5.1.1 I base, in-place upgrade, to correct the problems.
Quantity in commerce: 16 units
Distribution: Nationwide Distribution including PR and the states of IL, IN, FL, GA, MD, MI, MO, MS, NC, NY, OR, and PA, PR and the country of Canada.
Product codes and lots: Software Versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1612-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1612-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-20	2015-05-14

Product code DQK

K023112Class IIProsolv Cardivascular Viewer; Analyzer; Server; Version 2.5.9Problem Solving Concepts, Inc. / cleared 2002-12-17

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)