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Recall Observatory FDA recall evidence

Device product

Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

Z-0335-2014

October 11, 2013

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 66601
Status
Terminated
Classification
Class II
Quantity
9 units
Official record key
device-enforcement:Z-0335-2014

Official wording

Reason: If the couch, with the footrest extension attached, is positioned where the table travel is within the bore of the gantry, and the user begins to lower the couch, the footrest extension can contact the gantry cover or come in contact with the user due to the length of the accessory.

Code information: Model #728306, Serial #'s: 100016, 100018, 100019, 100020, 100021, 100022, 100023, 100024 and 100025.

Distribution pattern: Worldwide distribution: USA (nationwide) Distribution in the states of DC, GA, IL, IN, NY and OH and the countries: Germany, Israel and Netherlands.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    If the couch, with the footrest extension attached, is positioned where the table travel is within the bore of the gantry, and the user begins to lower the couch, the footrest extension can contact the gantry cover or come in contact with the user due to the length of the accessory.