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U.S. Department of Health and Human Services

Class 2 Device Recall Synapse CV

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  Class 2 Device Recall Synapse CV see related information
Date Initiated by Firm January 03, 2024
Date Posted February 21, 2024
Recall Status1 Open3, Classified
Recall Number Z-1172-2024
Recall Event ID 93855
510(K)Number K151859  
Product Classification System, image processing, radiological - Product Code LLZ
Product Synapse CV 6. with AR.
A web-based application as the primary user interface for the processing of medical images.
Code Information UDI-DI 00854904006015 Software versions 6.2.1, 6.2.0, 6.1.1, 6.1.0, 6.0.1, and 6.0.0
Recalling Firm/
Manufacturer		 FUJIFILM Healthcare Americas Corporation
81 Hartwell Ave Ste 300
Lexington MA 02421-3160
For Additional Information Contact
617-861-5300
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Software design
Action 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.
Quantity in Commerce 8
Distribution US domestic distribution nationwide. International distribution to Israel.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
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