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U.S. Department of Health and Human Services

Class 2 Device Recall FujiMedical

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  Class 2 Device Recall FujiMedical see related information
Date Initiated by Firm February 04, 2015
Date Posted May 14, 2015
Recall Status1 Terminated 3 on September 20, 2018
Recall Number Z-1611-2015
Recall Event ID 70891
510(K)Number K023112  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product FujiMedical Synapse Cardiovascular I ProSolv CardioVascular.
A picture Archiving and Communication System
Software versions:
Synapse Cardiovascular v4.0.8
Synapse Cardiovascular v4.0.8 SR1
Code Information Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
Recalling Firm/
Manufacturer		 Fujifilm Medical Systems U.S.A., Inc.
419 West Ave
Stamford CT 06902-6343
For Additional Information Contact
203-324-2000
Manufacturer Reason
for Recall		 Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.
FDA Determined
Cause 2		 Software in the Use Environment
Action FujiMedical Systems North America issued intial recall letter dated February 4, 2014, advising users of the HL7 report exported to the EMR wherein measurement values presented in the Hl7 reports in your EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report. Follow-up letters were issued February 12, 2014, and July 24, 2014. A mandatory upgrade to software version 5.1.1/ base, in-place upgrade required. A customer response form attached to acknowledge receipt and arrange for the on site upgrade. For questions regarding this recall call 203-324-2000.
Quantity in Commerce 30 units
Distribution Worldwide Distribution - US including CA, FL, IL, IN, MD, MI, MN, MO, NC, NY, OH, OR, PA, PR, TX, VA, WI Foreign: Canada
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQK and Original Applicant = PROBLEM SOLVING CONCEPTS, INC.
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