AGFA Corp. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
AGFA Corp.
Lot Codes / Batch Numbers
Product Version 6.3.1 SU10.
Products Sold
Product Version 6.3.1 SU10.
AGFA Corp. is recalling Agfa Impax R6.3 DB Server. Impax Systems are Picture Archiving and Communication systems (PACs). P due to Measurements are inaccurate on multiple workstations.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Measurements are inaccurate on multiple workstations.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026