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.
FDA Recall Z-1662-2014 · Posted 2014-05-27
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Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2014-04-30
Date Terminated2014-09-18
Product QuantityOne
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Distribution to SC only
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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