Device product
Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (d) A description of the defect in the
Z-0236-2015
Product summary
- Event
- Event 69356
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16 systems
- Official record key
device-enforcement:Z-0236-2015
Official wording
Reason: It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location.
Code information: Software version 4.1.
Distribution pattern: US Distribution
Derived failure modes
-
Device software or design
software defect