| Class 2 Device Recall IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting | |
Date Initiated by Firm | March 15, 2013 |
Date Posted | April 08, 2013 |
Recall Status1 |
Terminated 3 on January 09, 2014 |
Recall Number | Z-1070-2013 |
Recall Event ID |
64656 |
510(K)Number | K050228 |
Product Classification |
System, image processing, radiological - Product Code LLZ
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Product | IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting.
Facilitates digital reports for catheterization, echocardiography, and congenital heart disease. |
Code Information |
Model # L9M21000. Software versions: IMPAX CV 7.8, 7.8 SU1, 7.8 SU2 and 7.8 SU3, IMPAX CV 7.8 SU2.5 with IMPAX CV Outbound Report Stylesheet 7.8_HL |
Recalling Firm/ Manufacturer |
AGFA Corp. 10 S Academy St Greenville SC 29601-2632
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For Additional Information Contact | Debbie Huff 864-421-1754 |
Manufacturer Reason for Recall | Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic health record (EHR) system. |
FDA Determined Cause 2 | Software design |
Action | AGFA sent an "URGENT FIELD SAFETY NOTICE" letter dated March 15, 2013 to the consignees who use the IMPAX CV Reporting tool described for this issue. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 877-777-2432, referencing HQ_10020006 for questions regarding this notice. |
Quantity in Commerce | 26 |
Distribution | Nationwide Distribution including the states of AK, GA, IL, KY, MA, NY, NC, RI, SC, TX, and VA. |
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 = LLZ
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