Data Foundry

Medical device recalls 2016

Philips Healthcare Brilliance iCT Computed Tomography X-Ray System — Class II medical device recall Z-1714-2016

Terminated recall by Philips Healthcare, reported 2016-06-15, distributed in AL, AR, AZ, CA, CO, DC, FL, GA…. Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on c

Recall numberZ-1714-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPhilips Healthcare, Andover, MA, United States
Recall initiated2015-09-06
Classified2016-06-06
Reported by FDA2016-06-15
Terminated2021-03-04
DistributedAL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, LA, MA, MD, MN, MO, MS, NC, NV, NY, OH, OK, OR, PA, SC, TX, VA, VT, WA
Quantity423
Reason classessoftware

Product

Philips Healthcare Brilliance iCT Computed Tomography X-Ray System

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1714-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.