Z-1611-2015Class II

FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System...

Name: Z-1611-2015 FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System...
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 FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synapse Cardiovascular v4.0.8... on 2015-02-04. FDA classified it as Class II and gives the reason as "Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular 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-1611-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-04
Posted: 2015-05-14
Terminated: 2018-09-20
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: FujiMedical Systems North America issued intial recall letter dated February 4, 2014, advising users of the HL7 report exported to the EMR wherein measurement values presented in the Hl7 reports in your EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report. Follow-up letters were issued February 12, 2014, and July 24, 2014. A mandatory upgrade to software version 5.1.1/ base, in-place upgrade required. A customer response form attached to acknowledge receipt and arrange for the on site upgrade. For questions regarding this recall call 203-324-2000.
Quantity in commerce: 30 units
Distribution: Worldwide Distribution - US including CA, FL, IL, IN, MD, MI, MN, MO, NC, NY, OH, OR, PA, PR, TX, VA, WI Foreign: 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-1611-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1611-2015	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)