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Philips Medical Systems (Cleveland) Inc recalls Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers fu
Recalled July 18, 2012 · FDA recall Z-1988-2012 · Philips Medical Systems (Cleveland)
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 · FDA Class II
Units
96
Sold at
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.
Description
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
Product
Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise.
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →