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
This recall has been terminated (originally issued December 16, 2014).
- Company
- Philips Medical Systems, Inc.
- Recall Initiated
- July 31, 2014
- Posted
- December 16, 2014
- Terminated
- February 16, 2017
- Recall Number
- Z-0236-2015
- Quantity
- 16 systems
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location.
Distribution
US Distribution
Lot / Code Info
Software version 4.1.
Root Cause
Radiation Control for Health and Safety Act
Action Taken
Philips Healthcare is directly notifying affected users via letter. In addition, Philips Healthcare has performed the software correction for forward production and plans a Field Correction to fix the defect in the field. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office.
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