Apr

2011

Cl ll Brilliance 64

Company: Philips Medical Systems, Inc.
Date of Enforcement Report 4/13/2011
Class ll:

PRODUCT
Extended Brilliance Workstation (EBW) a component of the Computed Tomography The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes; Model #728231. Recall # Z-1820-2011

REASON
During the version 2.6 software upgrade, the system was not recalibrated with the infant phantom for the infant protocol.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated January 31, 2011. FDA initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
9 units

DISTRIBUTION
CO, IN, TN, Norway, Israel, and Germany

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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Cl ll Brilliance 64

Amy Sellers

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