Agfa Impax R6.3 DB Server. Impax Systems are Picture Archiving and Communication systems (PACs). PAC systems are used in the acceptance, transfer, display, storage and digital processing of medical images. Primary users are radiologists, mammographers, orthopaedists and other trained medical staff.
- Company
- Agfa Corp.
- Recall Initiated
- July 16, 2009
- Posted
- September 8, 2009
- Terminated
- April 28, 2011
- Recall Number
- Z-1887-2009
- Quantity
- One unit
- Firm Location
- Greenville, SC
Reason for Recall
Measurements are inaccurate on multiple workstations.
Distribution
Nationwide Distribution -- IL
Lot / Code Info
Product Version 6.3.1 SU10.
Root Cause
Software design
Action Taken
Agfa Healthcare issued an "URGENT FIELD SAFETY NOTICE" dated July 16, 2009. The notice informed of the problem and provided details to identify potentially compromised data that could result in measurement inaccuracies. A feedback form was provided to be completed and returned to the firm. For further information, contact Agfa Healthcare at 1-773-592-4769.
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