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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Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to

office@softwarecpr.com by Sep 25, 2019 if possible!

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