Company:AGFA Corp
Date of Enforcement Report 1/11/12
Class ll:
PRODUCT
IMPAX Cardiovascular Results Management (RM) Software Versions RM 2.04.37.04 to RM 7.8 SU2. Recall # Z-0211-2012
REASON
Improper merging of IMPAX Cardiovascular Results Management (RM) reports causes the signed report to become unavailable.
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by letter dated May 27, 2011.
Manufacturer: AGFA HealthCare Corp., Westerly, RI. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
323 units
DISTRIBUTION
Nationwide and Canada