26

Apr

2012

Cl ll Brilliance Workspace IntelliSpace Portal

0

Company:Philips Medical Systems
Date of Enforcement Report 4/25/12
Class ll:

PRODUCT
Brilliance Workspace IntelliSpace Portal, M/N 728269, The Brilliance Workspace Portal is a 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, patient, and equipment supports, components and accessories. System Code # 881001. Recall # Z-1337-2012

REASON
A number of non-conformances were logged for IntelliSpace Portal running software version 4.0 during in-house random verification testing. When loading a study to Review, after failing to load it through Add to Running Application the Analysis application is not being closed and different (1st loaded study) patient appears in analysis (CCA).

RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, letter dated February 23, 2012. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
90 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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