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Recall Observatory FDA recall evidence

Device product

Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body 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. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

Z-0950-2013

February 15, 2013

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 64436
Status
Terminated
Classification
Class II
Quantity
42 Units
Official record key
device-enforcement:Z-0950-2013

Official wording

Reason: This field change order is being released to update software and customer release notes to the affected installed base.

Code information: Brilliance 64: 728231 & Ingenuity CT: 728326, 728323. System Code # 728231, Serial #: 9654, 91003, 95130, 95157, 95504 System Code # 728326, Serial #: 32000,300003,300004,300005,300010,300011,300012,300014,300015,300018,300027,300041,300053,300059,300066,300070,300071,300073,300074,300078,300079,300080,300082,300084,300086,300091,300095,300101,300102,300112,300127,300128,300129,300131,300132,310064 System Code # 728323, Serial #: 320033

Distribution pattern: Worldwide Distribution - USA including AR, AZ, IN, KS, LA, MA, MN, MS, MT, NJ, NY, NY, OH, OR, PA, TN, TX, VT, WV, WY, and worldwide including the contries of Australia, Belgium, China, France, Germany, Israel, Japan, Norway, Sweeden, and Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    This field change order is being released to update software and customer release notes to the affected installed base.