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Terminated

NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.

FDA Recall Z-0466-2013 · Posted 2012-12-04

Recalling FirmPhilips And Neusoft Medical Systems Co., Ltd.
Recall StatusTerminated
Product CodeJAK
Date Initiated2012-10-18
Date Terminated2013-07-08
Product Quantity20 units of NeuViz 16 CT Scanner Systems and 25 units of NeuViz Dual series

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.

Firm Action

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 [email protected] For questions regarding this recall call 425-487-7665.

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092742NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEMNeusoft Medical Systems Co., Ltd. · 2009-09-22K090173NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEMNeusoft Medical Systems Co., Ltd. · 2009-02-05K071308MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEMNeusoft Medical Systems Co., Ltd. · 2007-08-16K062451NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEMNeusoft Medical Systems Co., Ltd. · 2006-09-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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