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Recall Observatory FDA recall evidence

Device product

Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System

Z-1719-2016

September 06, 2015

Class II

Product summary

Firm
Philips Healthcare
Event
Event 74149
Status
Terminated
Classification
Class II
Quantity
US - 423
Official record key
device-enforcement:Z-1719-2016

Official wording

Reason: 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

Code information: Software v. 4.13, 4.14 and 4.15.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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