FDA Enforcement
Class II
Terminated
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
Recall: Z-0236-2015
·
Reported December 24, 2014
Enforcement
- Recall Number
- Z-0236-2015
- Event ID
- 69356
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips Medical Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 24, 2014
- Initiation Date
- July 31, 2014
- Classification Date
- December 16, 2014
- Termination Date
- February 16, 2017
- Address
- 3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States
Description
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
Reason
It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location.
Code Info
Software version 4.1.
Distribution
US Distribution
Quantity
16 systems