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.
- Company
- Agfa Corp.
- Recall Initiated
- April 30, 2014
- Posted
- May 27, 2014
- Terminated
- September 18, 2014
- Recall Number
- Z-1662-2014
- Quantity
- One
- Firm Location
- Greenville, SC
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.
Distribution
Distribution to SC only
Lot / Code Info
Model L9M21000 - Software versions: IMPAX CV 7.8 SU3/SU4 - OCR Service
Root Cause
Software design
Action Taken
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.