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Philips Medical Systems (Cleveland) Inc recalls Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.
Recalled April 23, 2014 · FDA recall Z-1464-2014 · Philips Medical Systems (Cleveland)
Hazard
A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions would intermittently not complete. · FDA Class II
Units
116 units
Sold at
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.
Description
A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions would intermittently not complete.
Product
Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →