Synapse CV 6 Imaging Software Calculation Error May Cause Misdiagnosis
FUJIFILM Synapse CV 6 medical imaging software may incorrectly calculate left ventricle mass measurements. If used for diagnosis, this calculation error could lead to patient misdiagnosis and incorrect treatment, potentially causing long-term health consequences.
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: FDA Class II recall without reported illnesses, injuries, or deaths. The hazard is theoretical—a risk of misdiagnosis and incorrect treatment if the calculation error is used as a primary diagnostic factor—but no actual harm has been documented. This fits the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
FUJIFILM Healthcare Americas Corporation has recalled Synapse CV 6 medical imaging software (versions 6.2.1, 6.2.0, 6.1.1, 6.1.0, 6.0.1, and 6.0.0) due to a calculation error affecting cardiac measurements.
The software's LV Mass (2D Bullet) equation may be calculated incorrectly. When used to measure left ventricle mass as a primary diagnostic factor, this error could result in inaccurate measurements and lead to patient misdiagnosis or an incorrect treatment plan.
The software has been distributed nationwide in the United States and internationally to Israel.
Healthcare facilities and providers currently using affected versions should contact FUJIFILM Healthcare Americas Corporation to determine if they are affected and to obtain updated software or additional guidance.
The recalled product
- Product
- Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
- Manufacturer
- FUJIFILM Healthcare Americas Corporation
- Affected units
- 8
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 (6)
- UDI-DI 00854904006015 Software versions 6.2.1
- 6.2.0
- 6.1.1
- 6.1.0
- 6.0.1
- and 6.0.0
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by FUJIFILM Healthcare Americas Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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