Recall Z-2307-2008 ยท JAK System, X-Ray, Tomography, Computed
Philips And Neusoft Medical Systems Co., Ltd.
NeuViz Dual series computed Tomography Scanner System, X-Ray System
| Date | Sep 17, 2008 (initiated Jun 23, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| Quantity | 15 units in US |
| Distribution | The units were distributed to one distributor in NC, and further distributed to medical facilities located in CO, FL, KY, NC, SC, TN and TX. |
| FDA record | Open on fda.gov |