The device is the NeuViz Dual series Computed Tomography (CT) Scanner System. The device is identified as NeuViz Dual, P

FDA device recall Z-0846-2011 · posted 2011-01-04 · Terminated

Recall details

Recalling firm

Philips And Neusoft Medical Systems Co., Ltd.

Reason for recall

Potential for the CT patient table top to become detached from the carrier due to missing washers.

Action taken

Neusoft Medical Systems Co., China sent an URGENT DEVICE CORRECTION letter dated Feb. 10, 2010 to their distributor in NC. On 02/12/10, The distributor sent the same letter to their consignees. The firm informed this distributor that there was report of the four screws that secure the patient table top to the carrier that did not have the proper washers in place which caused the table top to detach. If the issue would reoccur, there is a potential for the table top to fall and cause patient injury. Customers were instructed to check the patient table top fixing. If it is found that the the assembly is improper customers were instructed to top using the product and contact local Service personnel for repair. Any customer can contact Service Support Department, Neusoft Medical Systems Co, LTD at nms-service@neusoft.com or Service Support Department at helpdesk@neusoft.com for questions about this recall.

Root cause

Other

Status

Terminated

Product code

JAK

Quantity affected

26 devices

Distribution

Nationwide Distribution including NC

Date initiated

2010-02-10

Date posted

2011-01-04

Date terminated

2011-04-15

Location

Shenyang, Liaoning, China

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