device · product 1 of 1
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.
- Recall number
- Z-2709-2014
- Initiated
- December 27, 2005
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 364
App-derived interpretation
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.
Official device-enrichment evidence · Sourced
Device Design
Inspect official wording and provenance
Reason for recall
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.