Company: Philips Healthcare
Date of Enforcement Report 6/15/2016
Class lI:
PRODUCT
Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
Recall Number Z-1714-2016
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
RECALLING FIRM/MANUFACTURER
Philips Healthcare, Andover, MA on 9/6/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
423
DISTRIBUTION
Nationwidewide
___________________________________
