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Philips Healthcare recalls Philips Healthcare Ingenuity Core Computed Tomography X-Ray System
Recalled June 15, 2016 · FDA recall Z-1716-2016 · 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 · FDA Class II
Units
US-423
Sold at
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.
Description
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
Product
Philips Healthcare Ingenuity Core Computed Tomography X-Ray System
Manufacturer(s)
Philips Healthcare
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →