Cl ll Philips Intellispace Portal

Company:Philips Medical Systems Nederlands.
Date of Enforcement Report 3/7/12
Class ll:

PRODUCT
Philips Intellispace Portal, Release 4.0.0. For storing, processing and management of electronic information/data Model: 881001. Indicated for use as a diagnostic device. Recall # Z-1125-2012

REASON
There maybe incorrect values in the diffusion/perfusion maps.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems Nederlands, Best, Netherlands, by letter dated January 20, 2012. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
25 units

DISTRIBUTION
Nationwide and Internationally

About the author

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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Or just email training@softwarecpr.com for more info.

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