Fujifilm Synapse PACS Software Version 5.6.1 Recalled for CT Measurement Error
Fujifilm is recalling Synapse PACS Software Version 5.6.1 because certain CT studies may report inaccurate 3D Sphere MAX values.
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. It is a software defect affecting measurement accuracy without reported harm, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling Synapse PACS Software Version 5.6.1. 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 nationwide in the United States, including Minnesota.
The recall is due to a potential software defect where certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to the 3D Sphere tool; other density tools are not affected. No specific number of affected units or reported injuries is provided in the source text.
Healthcare providers should contact Fujifilm for instructions on how to address the issue. Consumers are not directly affected as this is a professional medical device software.
The recalled product
- Product
- Synapse PACS Software Version 5.6.1 - 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
- 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)
- Synapse Software Version 5.6.1
Distribution
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