Philips Healthcare recalls Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System

Recall date

September 6, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1718-2016

FDA classification

Class II

Brand / firm

Philips Healthcare

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System