Reported Jul 3, 2013 · Terminated

Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray…

Philips Medical Systems (Cleveland) Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips Medical Systems (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131

Is this the product you have?

  • 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.
Lot codes and dates
  • 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
Amount recalled
50 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 27, 2013 · Data as of Sep 19, 5:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.