FDA Enforcement
Class II
Terminated
Brilliance iCT. Computed Tomography X-ray systems 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-1656-2015
·
Reported June 3, 2015
Enforcement
- Recall Number
- Z-1656-2015
- Event ID
- 71177
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips Medical Systems (Cleveland) Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 3, 2015
- Initiation Date
- March 16, 2015
- Classification Date
- May 22, 2015
- Termination Date
- February 22, 2017
- Address
- 595 Miner Rd, Cleveland, OH, 44143-2131, United States
Description
Brilliance iCT. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Reason
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
Code Info
System Code #, 728306, Serial #, 100067, 100137, 100179, 100226, 100233, 100293, 100294 & 100342.
Distribution
Distributed in China.
Quantity
153 units total