NeuViz Dual series computed Tomography Scanner System, X-Ray System The CT scanner is a whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle.
Recall
- Recall Number
- Z-2235-2008
- Event Number
- 48657
- Firm
- Philips And Neusoft Medical Systems Co., Ltd. Neusoft Park, Hun Nan Industrial Area Shenyang, Liaoning China
- FEI Number
- 3003575350
- Product Code
- JAK
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- December 17, 2007
- Posted
- September 17, 2008
- Terminated
- February 16, 2012
Description
NeuViz Dual series computed Tomography Scanner System, X-Ray System The CT scanner is a whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle.
Labeling of patient position on scanned image does not match actual patient orientation.
On 12/17/08 the distributor sent a letter dated 12/13/07 to their customers explaining the problem and under what circumstances it can occur, the actions that should be taken by the customer/user in order to prevent risks for patients or users, and that the customer/user will be contacted for scheduling of a software upgrade by the distributor. Contact NEUISYS Service Support Department at 1-877-299-9052 for assistance.
Distribution in US: CO, FL, KY, NC, SC, TN, and TX.
15 units