FUJIFILM Healthcare Americas Corporation Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
Brand
FUJIFILM Healthcare Americas Corporation
Lot Codes / Batch Numbers
UDI-DI 00854904006015 Software versions 6.2.1, 6.2.0, 6.1.1, 6.1.0, 6.0.1, and 6.0.0
Products Sold
UDI-DI 00854904006015 Software versions 6.2.1, 6.2.0, 6.1.1, 6.1.0, 6.0.1, and 6.0.0
FUJIFILM Healthcare Americas Corporation is recalling Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of due to The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting in long-term health consequences or serious deterioration of health.
Recommended Action
Per FDA guidance
On January 3, 2024, the firm notified customers via URGENT MEDICAL DEVICE CORRECTION letters. Fujifilm will offer to correct the formula that calculates the LV Mass (2D Bullet) in the Synapse database. Until the update is scheduled and completed, customers may continue to safely use the Pediatric Workflow modules listed in the notice as long as the LV Mass (2D Bullet) equation is not the main factor for a diagnosis. Customers should coordinate with the Fujifilm service engineer to schedule the correction of their device when contacted. Please contact Fujifilm's field action coordinator, Kotei Aoki, via phone at 765-246-2931 or email at kotei.aoki@fujifilm.com, if you have any further questions regarding this field action.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026