Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Fujifilm Medical Systems

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Fujifilm Medical Systemssee related information
Date Initiated by FirmFebruary 04, 2015
Date PostedMay 14, 2015
Recall Status1 Terminated 3 on September 20, 2018
Recall NumberZ-1612-2015
Recall Event ID 70890
510(K)NumberK023112 
Product Classification Computer, diagnostic, programmable - Product Code DQK
ProductFujifilm 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
FEI Number 1000513161
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
ActionFujifilm 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 Commerce16 units
DistributionNationwide 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 CycleTPLC 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) Database510(K)s with Product Code = DQK
-
-