Company:Philips Electronics North America Corporation
Date of Enforcement Report 10/25/2017
Class lI:
PRODUCT
Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These computed tomography x-ray systems are 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-0016-2018
REASON
During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. There is a discrepancy between the calculated reconstruction length and the actual scan length that results in the inability to reconstruct raw data
RECALLING FIRM/MANUFACTURER
Philips Electronics North America Corporation, Andover, MA on 1/18/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
606
DISTRIBUTION
Nationwide
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