04

Apr

2012

Cl ll Brilliance Workspace Port

0

Company:Philips Medical Systems Inc.
Date of Enforcement Report 4/4/12
Class ll:

PRODUCT
The Brilliance Workspace Portal is a software component of the Computed Tomography X-Ray System. The Brilliance Workspace Portal is a software component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment.

REASON
Incorrect Standardized Uptake Value (“SUV”) values are displayed in two instances: 1. After loading PET data (with a Slope value different than 1) into the Quick Review (QR) application from a remote device; and 2. During the loading the above mentioned type of PET data into the CT viewer application from a remote device.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated February 08, 2012. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
822 units

DISTRIBUTION
Nationwide and Internationally

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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