Device Recall NeuViz Dual series computed Tomography Scanner System 의 리콜

Recall

48727

Class 2

Z-2307-2008

2008-06-23

2008-09-17

Terminated

United States

2010-09-24

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72008

Potential for r-host box and components inside to be detached of its mounting during the gantry rotor rotation. there is a potential for components to be damaged inside the system gantry and for the internal components to be expelled from the system gantry and injure the patient, operator, bystander or service people.

On 6/23/08/08, the Philips Neusoft sent a letter dated 6/10/08 to their US customers explaining the problem, under what circumstances it can occur, and the actions that should be taken by the customer/user in order to prevent risks for patients or users. The field correction is install a R-host bracket to aid supporting of the R-host computer. The letter included additional information to customers who had already received the field action (this was an on-going activity that was re-classified as a potential safety). Customers did not receive the additional information about the status of their upgrade if the upgrade had not occurred at the time of the mailing. They were informed that they would be contacted by Newsoft Medical systems representative for the planning of this repair. If you have questions contact Service Support Department at nms-service@neusoft.com.