FDA-Device2018-03-14Class II
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
Philips Medical Systems (Cleveland) Inc
Hazard
23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or incorrect treatment; " Software errors that may result in partial set of images or inability to generate CT images.
Sold states
Domestic and Foreign
Affected count
63
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0841-2018Don't want to check this manually?
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