Skip to content
Recall Observatory FDA recall evidence

Device product

Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provide cross sectional images of the human body and visualization of the internal organs.

Z-2709-2014

December 27, 2005

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 69123
Status
Terminated
Classification
Class II
Quantity
364
Official record key
device-enforcement:Z-2709-2014

Official wording

Reason: The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle to zero tilt angle.

Code information: 728256, 728251, 728246, 728240, and 728235.

Distribution pattern: Worldwide Distribution -- AZ, CO, GA, IA, IL, IN, KS, KY, MD, MI, MN, MS, NC, NY, OH, OK, TX, VT, and WI; and, countries of Singapore, New Zealand, India, Australia, Korea, Japan, Korea, China, India, Taiwan, Australia, Turkey, France, South Africa, Spain, Italy, Austria, Belgium, Switzerland, Israel, Netherlands, England, and Brazil.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The system has a gap that can appear between the upper and lower tilt stand covers. The fingers may be squeezed if a person was to place them in this region while the gantry was tilting from an angle to zero tilt angle.