FDA-Device2012-07-18Class II
Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise.
Philips Medical Systems (Cleveland) Inc
Hazard
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 diff
Sold states
Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, FL, GA, IA, IN, MI, NC, NJ, NY, OK, PA, SC, TN, TX, and WA and the countries of Australia, Austria, Canada, China, Czech Republic, Denmark, and France.
Affected count
96
Manufactured in
595 Miner Road, Cleveland, OH, United States
Products
Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1988-2012Don't want to check this manually?
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