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.
FDA Recall Z-1588-2013 · Posted 2013-06-25
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Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2013-03-21
Date Terminated2013-11-27
Product Quantity50 units
Reason for Recall
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 bol
Firm Action
Philips Medical Systems sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated Mar 21, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution-including the states of AR, AZ, DE, IN, KS, LA, MA, MN, MS, MT, NJ, NY, NY, OH, OR, PA, TN, TX, VT, WV, and WY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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