NeuViz Dual series computed Tomography Scanner System, X-Ray System

FDA device recall Z-2307-2008 · posted 2008-09-17 · Terminated

Recall details

Recalling firm

Philips And Neusoft Medical Systems Co., Ltd.

Reason for recall

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JAK

Quantity affected

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.

Date initiated

2008-06-23

Date posted

2008-09-17

Date terminated

2010-09-24

Location

Shenyang, Liaoning, China

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