Company:AGFA Corp
Date of Enforcement Report 7/6/2011
Class ll:

PRODUCT
IMPAX 6.5 Client Software. IMPAX 6.5 combines the traditional activities of RIS informatics management with PACS image management to provide a powerful platform for imaging-based planning, interpretation, and results distribution. The IMPAX 6.5 Client focuses on the integration of PACS, RIS and Speech applications into a single delivery of information. A single IMPAX 6.5 Client application can be used by a range .

REASON
Software issue that occurs after dictation of a study.

RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp. Greenville, SC, by letter on April 14, 2011.
Manufacturer: Agfa Healthcare Corp., Carlstadt, NJ. Firm initiated recall is ongoing.
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VOLUME OF PRODUCT IN COMMERCE
95 units

DISTRIBUTION
Nationwide