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U.S. Department of Health and Human Services

Class 2 Device Recall Fujifilm

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  Class 2 Device Recall Fujifilm see related information
Date Initiated by Firm April 30, 2021
Create Date June 02, 2021
Recall Status1 Open3, Classified
Recall Number Z-1775-2021
Recall Event ID 87938
510(K)Number K151859  
Product Classification System, image processing, radiological - Product Code LLZ
Product Synapse Cardiovascular (Synapse CV).
Software Versions: 6.0 to 6.2.1
The Synapse Cardiovascular image is a management and reporting system
Code Information Software Versions: 6.0 to 6.2.1
Recalling Firm/
Manufacturer
Fujifilm Medical Systems U.S.A., Inc.
81 Hartwell Ave Ste 300
Lexington MA 02421-3160
For Additional Information Contact SAME
617-861-5300
Manufacturer Reason
for Recall
Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does not increase when a patient merge activity is executed in a specific sequence
FDA Determined
Cause 2
Software design
Action Fujifilm issue consignee notifications via email on April 30, 2021. Letter states reason for recall, health risk and action to take: ACTIONS TO BE TAKEN BY CUSTOMER/END USER FUJIFILM will offer an upgrade to Synapse CV 6.2.2 to resolve this issue. FUJIFILM recommends the following actions: 1) Complete and return the Field Action Verification Form attached on page 3 of this communication. Providing the response with the information requested is essential for ensuring appropriate action is taken. 2) Contact Customer Service at 1-888-FUJIMED (1-888-385-4633) to open a ticket for the upgrade. Until your upgrade is scheduled and completed, Advanced Reporting users can continue to safely use Synapse CV by choosing one of the following options: 1) Merge the older patient record to the newer patient record, and then delete the older patient record. This sequence retains the most recent internal patient database ID and deletes an older internal patient database ID that will not be erroneously reassigned. 2) Merge the newer patient record to the older patient record only after additional new patients have been added beyond the record you want to merge. This sequence ensures that the most recent internal patient database ID is assigned to a record that is not involved in the merge activity. 3) Always check patient information presented in the report with other information provided for that patient/study. Please contact our field action coordinator, Jeffrey Wan, via phone at 201-675-8947 or email at jeffrey.wan@fujifilm.com, if you have any further questions regarding this field action.
Quantity in Commerce 44 US and 4 OUS
Distribution Worldwide distribution - US Nationwide distribution and the countries of Canada, Bermuda, Israel, Hadassah Medical Center.
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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