Cl II Philips Healthcare Brilliance iCT SP

Company: Philips Healthcare
Date of Enforcement Report 6/15/2016
Class lI:

PRODUCT

Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System
Recall Number Z-171Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System-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

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