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
