Fujifilm Synapse Cardiovascular Software Recalled for Inaccurate EMR Measurements
Fujifilm Medical Systems is recalling Synapse Cardiovascular software because measurement values in the EMR may not match clinical reports.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that could lead to inaccurate clinical data, representing a risk of harm to patients through incorrect medical records, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling 30 units of FujiMedical Synapse Cardiovascular I ProSolv CardioVascular software, versions v4.0.8 and v4.0.8 SR1. This Picture Archiving and Communication System (PACS) is used for cardiovascular imaging.
The recall was initiated because measurement values in the Electronic Medical Record (EMR) may not accurately reflect the actual measurement values found on the Synapse Cardiovascular clinical report. This discrepancy could lead to incorrect data being recorded in patient charts.
The affected software was distributed worldwide, including in the United States (California, Florida, Illinois, Indiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Texas, Virginia, and Wisconsin) and Canada. Users of this software should contact Fujifilm Medical Systems for further instructions on how to resolve the data accuracy issue.
The recalled product
- 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
- Fujifilm Medical Systems U.S.A., Inc.
- Category
- Medical Device — Software
- Affected units
- 30
Distribution
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