FDA-Device2014-04-23Class II
Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.
Philips Medical Systems (Cleveland) Inc
Hazard
A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions would intermittently not complete.
Sold states
Worldwide Distribution:US ( Nationwide) Including stages of MI, OR, PA, TX & WV; and Countries of: Australia, Bangladesh, Belgium, Brazil, Bulgaria, China, France, Germany, India, Indonesia, Ireland, Japan, Nicaragua, Oman, Palestine, Russia, South Korea, Spain, Switzerland, Thailand, Turkey & United Kingdom.
Affected count
116 units
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1464-2014Don't want to check this manually?
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