Jan

2017

Philips IQon Spectral CT Cl II

Company: Philips Medical Systems, Inc.
Date of Enforcement Report 1/18/20176
Class lI:

PRODUCT

IQon Spectral CT with software version 4.7.0Product Usage:The IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Recall Number Z-1006-2017

REASON
Multiple issues have caused the device to result in CT rescans or incorrect scan location or misrepresentation of image results.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Cleveland, OH on 12/162016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
35

DISTRIBUTION
Nationwide and Internationally

___________________________________

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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Philips IQon Spectral CT Cl II

Amy Sellers

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