Fujifilm Synapse PACS Software Recalled for Clinical Reporting Errors
Fujifilm Medical Systems is recalling Synapse PACS Software versions 7.0.0 and 7.0.1 because the software fails to update measurements when ventricular traces are changed by different users.
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 source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling FUJIFILM Synapse PACS Software versions 7.0.0 and 7.0.1. The software is intended for use as a web-based application on a PC networked with a FUJIFILM Synapse PACS server. The recall covers units distributed in the state of Maryland.
The recall was initiated because the software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user. This defect may result in inaccurate clinical reporting data.
Healthcare facilities using the affected software versions should contact Fujifilm Medical Systems U.S.A., Inc. for further instructions on how to resolve the issue.
The recalled product
- Product
- FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Versions 7.0.0 and 7.0.1
Distribution
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