Company: Philips Medical Systems
Date of Enforcement Report 1/2/2008
Class:ll

PRODUCT
a) Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on all Gemini TFs, GXLs and EBW Workstations. (The product is a software
application that is installed in Philips Medical System CT scanners.),
Recall # Z-0366-2008;
b) Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on all Brilliance CT scanners using software versions 2.0 through V 2.2.5 and all EBW workstations using software versions 2.0 through V3.5.2. (The product is a software application that is installed in Philips Medical System CT scanners.) Recall # Z-0367-2008

REASON
Incorrect Measurement: Incorrect measurement will occur when the operator uses the distance or area measurement function, such as Graphic Tool line or ROI on zoomed and batch saved images from the Cardiac Viewer or Pulmonary Viewer and then views them in the CT Viewer or on a PACS System.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland), Inc., Cleveland, OH, by letter on September 10, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2,544 units

DISTRIBUTION
Nationwide and Canada