03

Jan

2008

Philips Medical Systems Image Viewer Class II

0

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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