| Class 2 Device Recall FujiMedical | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DQK
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