Company: Philips Medical Systems, Inc.
Date of Enforcement Report 7/62016
Class lI:
PRODUCT
Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 scanner is a whole body 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-2118-2016
REASON
Philips Healthcare received reports from the field that certain Ingenuity Core 128 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Cleveland, OH on 4/1/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
19
DISTRIBUTION
US Nationwide Distribution in the states of CA, FL, ID, KS, MI, NY,OH,TX
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