FDA Recall
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
·
Initiated March 16, 2015
Recall
- Recall Number
- Z-1656-2015
- Event Number
- 71177
- Firm
- Philips Medical Systems (Cleveland) Inc
- FEI Number
- 1525965
- Product Code
- JAK
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- March 16, 2015
- Posted
- May 22, 2015
- Terminated
- February 22, 2017
- Address
- 595 Miner Rd, Cleveland, OH, 44143-2131
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.
Action
On 3-18-2015 the firm sent Urgent Field Safety Notices to their customers.
Distribution
Distributed in China.
Quantity
153 units total