Company:Philips Medical Systems
Date of Enforcement Report 7/18/12
Class ll:
PRODUCT
IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. The Philips Extended Brillance Workspace is intended for use as a diagnostic viewing and processing workstation. Z-1987-2012
REASON
The Intellispace Portal software and Extended Brillance Workspace software may have significantly different results in the colors and size of the affected area when the customer uses the “Time Sensitive” and “Time Insensitive” methods.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Cleveland, OH on 5/23/2012. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
38 units
DISTRIBUTION
Nationwide and Internationally
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