FDA Device

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.

Hazard

Measurements are inaccurate on multiple workstations.

What You Should Do

Remedy

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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Products

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
Brand
AGFA Corp.
UPC
Product Version 6.3.1 SU10.

Units Affected

One unit

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