Date Initiated by Firm | March 15, 2013 |
Date Posted | April 08, 2013 |
Recall Status1 |
Terminated 3 on April 01, 2014 |
Recall Number | Z-1069-2013 |
Recall Event ID |
64654 |
510(K)Number | K050228 |
Product Classification |
System, image processing, radiological - Product Code LLZ
|
Product | IMPAX CV 7.8 SU3 - OCR Service.
The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management. |
Code Information |
Softwaer version: IMPAX CR 7.8 SU3 Optical Character Recognition (OCR) Service |
Recalling Firm/ Manufacturer |
AGFA Corp. 10 S Academy St Greenville SC 29601-2632
|
For Additional Information Contact | Debbie Huff 864-421-1754 |
Manufacturer Reason for Recall | Software design error in IMPAX CV 7.8 SU3 |
FDA Determined Cause 2 | Software design |
Action | AGFA Healthcare sent an "URGENT FIELD SAFETY NOTICE" letter dated March 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed to distribute this information within your facility to all individuals who need to be aware of this. Please fax back to (864) 421-1664 that the information was received and understood was requested from the customers.
If you have any questions about this matter please contact your local AGFA Healthcare organization, or call (864) 421-1754. |
Quantity in Commerce | 2 |
Distribution | Distribute in the state of FL and KY |
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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