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U.S. Department of Health and Human Services

Class 2 Device Recall Fujifilm Medical Systems

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  Class 2 Device Recall Fujifilm Medical Systems 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-1612-2015
Recall Event ID 70890
510(K)Number K023112  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product Fujifilm Synapse Cardiovascular I ProSolv CardioVascular
Synapse Cardiovascular v4.0.8
Synapse Cardiovascular v4.0.8 SR1
Intended Use:
Picture Archiving and Communication System
Computer, Diagnostic, Programmable
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		 Under certain circumstances the patient Demographics in a report exported into the EMR may not match the demographics shown in the corresponding Synapse CV clinical report.
FDA Determined
Cause 2		 Software in the Use Environment
Action Fujifilm Medical on 2/4/14 , contacted users and advised to discontinue using HL7 reports pending FMSU determination of root cause. Firm issued follow-up letters on 2/24/14 and 7/24/14 advising users of a mandatory upgrade to version 5.1.1 I base, in-place upgrade, to correct the problems.
Quantity in Commerce 16 units
Distribution Nationwide Distribution including PR and the states of IL, IN, FL, GA, MD, MI, MO, MS, NC, NY, OR, and PA, PR and the country of 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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