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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 Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system. NeuViz Dual Multi-slice CT Scanner System is intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.
Recall Number Z-1166-2013
Classification Class II
Code Info Serial numbers: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002, NDHR080003, NDHR080004, NDHR080007, NDHR080012, NDHR080021, NDHR090003, NDHR090012, and NDHR090013.
Product Distributed Qty 25 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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