NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***".
FDA Recall Z-2083-2012 · Posted 2012-07-26
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Recalling FirmPhilips And Neusoft Medical Systems Co., Ltd.
Recall StatusTerminated
Product CodeJAK
Date Initiated2012-06-08
Date Terminated2012-09-17
Product Quantity15 units distributed in the US
Reason for Recall
One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz 16 CT scanner, which caused the Oil-accumulator to detach.
Firm Action
Philips Healthcare North America Company sent an "Urgent Device Correction NeuViz 16 X-Ray Tube Oil-accumulator Detached" letter and attachments of Annex A Method to Identify Affected Products and Annex B Instruction for Mechanic, dated June 14, 2012, to all affected customers.
The letter described the product, problem, and actions to be taken by the customers. Customers are advised to follow the instructions on Annex A and Annex B.
Philips and Neusoft Medical Systems planned to release the mandatory Field Change Order (FCO) and FCO kits to all customers by the end of June 2012.
If you have any questions about this corrective action program, please contact the Service Support Department, Neusoft Medical Systems, Co., LTD by e-mail to [email protected]
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution -- North Carolina, Ohio, and Texas.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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