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.
- Company
- Agfa Corp.
- Recall Initiated
- March 15, 2013
- Posted
- April 8, 2013
- Terminated
- April 1, 2014
- Recall Number
- Z-1069-2013
- Quantity
- 2
- Firm Location
- Greenville, SC
Reason for Recall
Software design error in IMPAX CV 7.8 SU3
Distribution
Distribute in the state of FL and KY
Lot / Code Info
Softwaer version: IMPAX CR 7.8 SU3 Optical Character Recognition (OCR) Service
Root Cause
Software design
Action Taken
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.
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