Company: Philips Medical Systems, Inc.
Date of Enforcement Report 8/31/2016
Class lI:
PRODUCT
Brilliance CT 16 Power, Model number 728240 Product Usage: Computed Tomography X-ray systems 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-2656-2016
REASON
After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Inc., Cleveland, OH on 8/25/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
50
DISTRIBUTION
Nationwide
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