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
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