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Fujifilm Medical Systems U.S.A., Inc. recalls FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software
Recalled May 20, 2015 · FDA recall Z-1611-2015 · Fujifilm Medical Systems U.S.A
Hazard
Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report. · FDA Class II
Units
30 units
Sold at
Worldwide Distribution - US including CA, FL, IL, IN, MD, MI, MN, MO, NC, NY, OH, OR, PA, PR, TX, VA, WI Foreign: Canada
Description
Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.
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
Manufacturer(s)
Fujifilm Medical Systems U.S.A., Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →