Fujifilm Synapse PACS Software Recalled for Inaccurate Ruler Measurements
Fujifilm is recalling Synapse PACS software v7.4.310 because a software issue may cause ruler measurements to be inaccurate.
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 inaccurate measurements which is a functional defect without reported injuries or hospitalizations, fitting the Moderate criteria for low-risk issues or voluntary precautionary recalls.
Plain-English summary
Fujifilm Healthcare Americas Corporation is recalling 6 units of FUJIFILM Synapse PACS software v7.4.310, a radiological image processing system. The recall is due to a software issue that may cause the ruler measurement tool to be inaccurate.
The affected units were distributed worldwide, including in the United States (New York, Virginia, Kansas, Oregon, and Ohio) and Australia. The specific units are identified by UDI (01)00854904006008(10)0704310 and serial numbers CV-00272120, CV-0080080176, CV-01318490, CV-01-80102732, CV-80057523, and CV-00494020-38.
Healthcare facilities and users should verify if they possess the affected software version and serial numbers. If the product is affected, users should contact Fujifilm Healthcare Americas Corporation for further instructions on remediation.
The recalled product
- Product
- FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
- Manufacturer
- FUJIFILM Healthcare Americas Corporation
- Category
- Medical Device — Software
- Hazard
- Affected units
- 6
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 (7)
- UDI (01)00854904006008(10)0704310
- Serial Numbers: CV-00272120
- CV-0080080176
- CV-01318490
- CV-01-80102732
- CV-80057523
- CV-00494020-38
Distribution
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