Company: Philips Medical Systems.
Date of Enforcement Report: 9/17/03
Class: II
PRODUCT
Easy Access PACS System with software. Recall # Z-471-3.
REASON
Potential display of an incorrect body part description on patient images.
CODE
Software Release 5, 6.2, or 7.2.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Bothell, WA, by letter on February 13, 2002. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
46 units.
DISTRIBUTION
Nationwide.
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Next public offering: TBD
