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U.S. Department of Health and Human Services

Enforcement Report - Week of May 1, 2013

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Product Detail

Product Description NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system. 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. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients
Recall Number Z-1165-2013
Classification Class II
Code Info Serial numbers: N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, N16E100023, N16E110016, N16E110023, N16E110026, N16E110027, N16E110040, N16E110053, N16E120016, N16E120020, N16E120022, N16E120023, N16E120024, N16E120052, N16E120053, and N16E130002.
Product Distributed Qty 23 units
Reason For Recall User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel.

Event Detail

Event Id 64783
Product Type Devices
Status Ongoing
Recalling Firm Philips And Neusoft Medical Systems Co., Ltd.
City Shenyang, Liaoning
State
Country CN
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-04
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide distribution: USA including states of: California, Connecticut, North Carolina, Nebraska, Ohio, South Carolina, Texas, and Puerto Rico.
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