May

2006

Class II Philips Medical Systems Inc.

Company: Philips Medical Systems Inc.,
Date of Enforcement Report:5/31/2006
Class:lI

PRODUCT
Extended Brilliance Workspace Imaging Workstation. An independent diagnostic viewing and processing workstation, for CT images. Software version 1.0 or 1.0.1, Recall # Z-0889-06

REASON
Due to a software deficiency that occurs in the combine mode, a patients image can be filmed over a different patients image.

CODE
All serial numbers

RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems (Cleveland) Inc, Cleveland, OH, by firm representative visit, beginning June 2004, firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
397 devices

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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Class II Philips Medical Systems Inc.

Amy Sellers

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