NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 98

FDA device recall Z-0466-2013 · posted 2012-12-04 · Terminated

Recall details

Recalling firm

Philips And Neusoft Medical Systems Co., Ltd.

Reason for recall

The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. This issue may affect NeuViz Dual and NeuViz 16 scanners.

Action taken

Philips and Neusoft Medical Systems Co., Ltd. sent an Urgent Device Correction NeuViz Dual, NeuViz 16 letter, dated Oct. 18, 2012, to all affected US customers and distributors. The letter described the product, problem, and actions to be taken by the customers. Customers are advised to: 1. Have a mechanic check the patient table top screws fixing. Detailed instructions are attached as Annex with the letter. 2. If it is found that table top screws are improperly assembled, stop using the product and contact local Service personnel for repair. Philips and Neusoft Medical Systems Co., Ltd is in the process of upgrading devices with aforementioned kits and will contact customers to arrange for an update to affected systems. If you have any questions about this corrective action program, please contact the Service Support Department, Neusoft Medical Systems Co. Ltd. at nms-service@neusoft.com For questions regarding this recall call 425-487-7665.

Root cause

Device Design

Status

Terminated

Product code

JAK

Quantity affected

20 units of NeuViz 16 CT Scanner Systems and 25 units of NeuViz Dual series

Distribution

Nationwide Distribution including North Carolina, Ohio, Texas, and Puerto Rico.

Date initiated

2012-10-18

Date posted

2012-12-04

Date terminated

2013-07-08

Location

Shenyang, Liaoning, China

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