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

___________________________________