Company: Philips Medical Systems (Cleveland) Inc
Date of Enforcement Report: 7/3/2013
Class ll:
PRODUCT
Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
Recall Number Z-1588-2013
REASON
If the operator selects a patient name from the worklist using the mouse and then selects a different patient name using the keyboard (arrow keys then press enter) the patient name that populates the exam information page is the patient name selected with the mouse. Also, it is possible to begin a normal clinical scan while the anti-virus scan is running. However, if the user is running a bolus tracking scan, typical real time information is not displayed to the user. The consequence is the user may initiate the clinical scan either earlier or later than desired resulting in a mistimed bolus. And, if the operator is running a bolus tracking scan at the time the anti-virus is scheduled to run and the operator ignores or is not aware of the McAfee VirusScan Notification message displayed on the screen, typical real time information will not be displayed to the user. The consequence is the user may initiate the clinical scan either earlier or later than desired resulting in a mistimed bolus.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc, Cleveland, OH on 3/21/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
50 units
DISTRIBUTION
Nationwide
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