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.
FDA Recall Z-1069-2013 · Posted 2013-04-08
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Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2013-03-15
Date Terminated2014-04-01
Product Quantity2
Reason for Recall
Software design error in IMPAX CV 7.8 SU3
Firm 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.
Root Cause
Software design
Distribution Pattern
Distribute in the state of FL and KY
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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