Date Initiated by Firm | April 30, 2014 |
Date Posted | May 27, 2014 |
Recall Status1 |
Terminated 3 on September 18, 2014 |
Recall Number | Z-1662-2014 |
Recall Event ID |
68211 |
510(K)Number | K050228 |
Product Classification |
System, image processing, radiological - Product Code LLZ
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Product | IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography. |
Code Information |
Model L9M21000 - Software versions: IMPAX CV 7.8 SU3/SU4 - 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 | Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service. |
FDA Determined Cause 2 | Software design |
Action | AGFA Healthcare sent an URGENT FIELD SAFETY NOTICE LETTER dated April 30, 2014, to the consignee describing the problem that had occurred, the actions being taken by Agfa and the actions Agfa has required the site to perform. As part of the correction Agfa requires the consignee to review the affected reports to confirm that the data is correct. If errors are found the consignee will need to correct the data. The consignee was asked to acknowledge, via FAX-Back to 864-421-1664 or email, that the information was received and understood by the consignee. For questions the consignee was instructed to contact their local Agfa HealthCare organization at 877-777-2432.
For questions regarding this recall call 864-421-1754. |
Quantity in Commerce | One |
Distribution | Distribution to SC only |
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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