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Recall Observatory FDA recall evidence

Device 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

Z-1612-2015

February 04, 2015

Class II

Product summary

Firm
Fujifilm Medical Systems U.S.A., Inc.
Event
Event 70890
Status
Terminated
Classification
Class II
Quantity
16 units
Official record key
device-enforcement:Z-1612-2015

Official wording

Reason: 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.

Code information: Software Versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.