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Terminated

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

FDA Recall Z-1612-2015 · Posted 2015-05-14

Recalling FirmFujifilm Medical Systems U.S.A., Inc.
Recall StatusTerminated
Product CodeDQK
Date Initiated2015-02-04
Date Terminated2018-09-20
Product Quantity16 units

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.

Firm 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.

Root Cause

Software in the Use Environment

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023112PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9Problem Solving Concepts, Inc. · 2002-12-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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