FDA Enforcement
Class II
Terminated
Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Recall: Z-0015-2018
·
Reported October 25, 2017
Enforcement
- Recall Number
- Z-0015-2018
- Event ID
- 78144
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips Electronics North America Corporation
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- October 25, 2017
- Initiation Date
- January 18, 2017
- Classification Date
- October 13, 2017
- Termination Date
- February 26, 2020
- Address
- 3000 Minuteman Rd, Andover, MA, 01810-1032, United States
Description
Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Reason
During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. There is a discrepancy between the calculated reconstruction length and the actual scan length that results in the inability to reconstruct raw data. The operator may choose to rescan the patient.
Code Info
Software version 4.16
Distribution
USA (nationwide) Distribution
Quantity
US - 606