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
Hazard
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.
What You Should Do
Remedy
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.
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Products
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, Diagnosti
- Brand
- Fujifilm Medical Systems U.S.A., Inc.
- UPC
- Software Versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
Units Affected
16 units