Jun

2016

Cl II Philips Healthcare Ingenuity Elite xray

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

PRODUCT

Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System
Recall Number Z-1719-2016

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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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II Philips Healthcare Ingenuity Elite xray

Amy Sellers

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