FDA-Device2016-06-15Class II
Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System
Philips Healthcare
Hazard
Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm
Sold states
US Distribution - AZ, PA, FL, DC, W VA, NC, SC, AR, OK, OH, NY, NV, TX, PA, IN, CA, MN, MA, DC, MS, MD, OR, IL, CO, MO, VT, IA, AL, LA, GA and WA.
Affected count
US - 423
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1719-2016Don't want to check this manually?
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