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U.S. Department of Health and Human Services

Enforcement Report - Week of August 1, 2012

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Event Detail

Event ID 62481
Product Type Devices
Status Ongoing
Recalling Firm Philips And Neusoft Medical Systems Co., Ltd.
City Shenyang, Liaoning
Country CN
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-08
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution -- North Carolina, Ohio, and Texas.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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***". Serial No.: N16E0 90002, N16E0 90003, N16E0 90004, N16E0 90007, N16E0 90008, N16E0 90010, N16E1 00015, N16E1 00017, N16E1 00023, N16E1 10016, N16E1 10023, N16E1 10026, N16E1 10027, N16E1 10040, and N16E1 10053. Class II 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. 15 units distributed in the US Z-2083-2012