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Recall Observatory FDA recall evidence

Device product

No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body.

Z-2678-2014

January 09, 2007

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 69102
Status
Terminated
Classification
Class II
Quantity
61
Official record key
device-enforcement:Z-2678-2014

Official wording

Reason: When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate.

Code information: Model 728243 Software version 2.2.1 and 2.2.2

Distribution pattern: Worldwide Distribution - US including MO, TX, MD, AR, VA, KY, RI, NJ, MA, NY, LA, PA, VT, SC, CA, OH, FL, MN, MI and Internationally to Netherlands, Canada, Finland, Austria, France, Malaysia, Denmark, Norway, UK, Australia, Belgium, New Zealand.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate.