Company:Philips Medical Systems
Date of Enforcement Report 7/18/12
Class ll:
PRODUCT
Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Recall Number Z-1988-2012
REASON
Philips is issuing a software update to the Intellispace Portal systems to address a number of non-conformances. The most frequent and severe non-conformance identified involves the portal setting of “PAC Integration”. This setting has a feature that allows the user to launch images of multiple patient studies into an application, but does not display a warning message informing the user that different patients have been selected.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Cleveland, OH on 5/23/2012. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
96 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
