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Recall Observatory FDA recall evidence

Device 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.

Z-1588-2013

March 21, 2013

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 65137
Status
Terminated
Classification
Class II
Quantity
50 units
Official record key
device-enforcement:Z-1588-2013

Official wording

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 bol

Code information: The following codes are affected by this recall:System Code #728231, Serial #: 9654, 91003, 95130, 95157, 95504 System Code #728326, Serial #: 32000,300003,300004,300005,300010,300011,300012,300013, 300014,300015,300018, 300027,300041,300053,300054, 300059, 300066, 300070,300071, 300073, 300074, 30077, 300078, 300079, 300080,300082,300084,300086,300091,300092, 300095, 300101, 300102,300112, 300119, 300127, 300128, 300129, 300131, 300132, 310064, 320030 System Code #728321, Serial #: 310096, 310070 System Code #728323, Serial #: 320033

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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