Fujifilm Synapse Cardiovascular Software Recall for Patient Demographic Mismatch
Fujifilm Medical Systems is recalling Synapse Cardiovascular software versions v4.0.8 and v4.0.8 SR1 because patient demographics in exported reports may not match the clinical reports.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a data integrity issue (demographic mismatch) rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity recall.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling 16 units of Synapse Cardiovascular software, specifically versions v4.0.8 and v4.0.8 SR1. The software is a Picture Archiving and Communication System (PACS) intended for diagnostic use. The recall is due to a defect where, under certain circumstances, the patient demographics in a report exported to the Electronic Medical Record (EMR) may not match the demographics shown in the corresponding Synapse CV clinical report.
The affected software was distributed nationwide, including Puerto Rico and the states of Illinois, Indiana, Florida, Georgia, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Oregon, and Pennsylvania, as well as Canada. The recall number is Z-1612-2015.
Healthcare facilities using this software should contact Fujifilm Medical Systems U.S.A., Inc. for instructions on how to resolve the issue. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- 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
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Category
- Medical Device — Software
- Affected units
- 16
Distribution
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Similar recalls
- HighFujifilm Synapse Cardiovascular Software Recalled for Inaccurate EMR Measurements
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- ModerateFujifilm Synapse PACS Software Recalled for Clinical Reporting Errors
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